Chrysalis Intelligence · Sponsors · Biomet, Inc.

Biomet, Inc.

Warsaw, IN, US · 17 510(k) clearances · 164 recalls

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Total clearances
17
2020-01-02 → 2026-07-01
Last 12 months
2
Product codes
11
Most recent
2026-07-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 4 2020-11-10
MBB Bone Cement, Antibiotic Class II Orthopedic 3 2022-12-28
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Class II Orthopedic 2 2022-02-07
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class II Orthopedic 1 2026-07-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II Orthopedic 1 2026-05-19
HTY Pin, Fixation, Smooth Class II Orthopedic 1 2024-05-22
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Orthopedic 1 2021-12-10
HRS Plate, Fixation, Bone Class II Orthopedic 1 2021-02-19
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 1 2020-04-15
HWC Screw, Fixation, Bone Class II Orthopedic 1 2020-02-24
JDS Nail, Fixation, Bone Class II Orthopedic 1 2020-02-20
Safety

Recalls (164)

Class I (serious)
0
Risk of injury / death
Total recalls
164
Currently ongoing
36
Most recent
2026-07-01
DateSeverityStatusRecall # ProductCodeReason
2026-07-01 Class II Ongoing Z-2871-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade… — Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac…
2026-07-01 Class II Ongoing Z-2870-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade… — Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac…
2026-07-01 Class II Ongoing Z-2869-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade… — Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac…
2026-07-01 Class II Ongoing Z-2868-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade… — Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac…
2026-07-01 Class II Ongoing Z-2867-2026 Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade… — Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac…
2025-09-23 Class II Ongoing Z-0212-2026 BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Rep… — There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
2025-09-09 Class II Ongoing Z-2619-2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 — The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
2024-10-21 Class II Ongoing Z-0477-2025 JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 — Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, …
2024-05-17 Class II Ongoing Z-2179-2024 RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206 — 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
2024-03-13 Class II Ongoing Z-1607-2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi… — Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
2023-11-02 Class II Ongoing Z-0570-2024 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 — One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packa…
2023-11-02 Class II Ongoing Z-0569-2024 Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 — One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packa…
2023-10-09 Class II Ongoing Z-0388-2024 Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0387-2024 Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0386-2024 Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0385-2024 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0384-2024 Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0383-2024 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0382-2024 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0381-2024 Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous jo… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0380-2024 Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0379-2024 Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous … — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0378-2024 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous join… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0377-2024 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0376-2024 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0375-2024 Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0374-2024 Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0373-2024 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0372-2024 Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0371-2024 Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or prev… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-10-09 Class II Ongoing Z-0370-2024 Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ… — Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of s…
2023-02-06 Class II Ongoing Z-1284-2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 — The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
2022-12-29 Class II Ongoing Z-1043-2023 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number… — Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
2022-12-29 Class II Ongoing Z-1042-2023 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number:… — Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
2022-12-15 Class II Ongoing Z-1018-2023 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjun… — Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be fo…
2022-11-29 Class II Ongoing Z-1036-2023 OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defect… — Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
2022-02-14 Class II Terminated Z-0812-2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item #… — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio…
2022-02-14 Class II Terminated Z-0811-2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed … — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio…
2022-02-14 Class II Terminated Z-0810-2022 BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG … — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio…
2022-02-14 Class II Terminated Z-0809-2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM… — Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio…
2022-01-07 Class II Terminated Z-0677-2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0676-2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0675-2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0674-2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0673-2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 11361… — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0672-2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113… — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0671-2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2022-01-07 Class II Terminated Z-0670-2022 Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 — The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have suff…
2021-06-02 Class II Terminated Z-2275-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2274-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2273-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2272-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2271-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2270-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2269-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2268-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2267-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2266-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2265-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2264-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2263-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2262-2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2261-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2260-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-06-02 Class II Terminated Z-2259-2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300 — Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
2021-01-15 Class II Terminated Z-1131-2021 Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis ass… — Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined th…
2020-12-23 Class II Terminated Z-0882-2021 A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation o… — The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and po…
2020-12-01 Class II Terminated Z-0723-2021 Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item … — Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
2020-11-25 Class II Terminated Z-0631-2021 RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill. — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0630-2021 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0629-2021 Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0628-2021 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrain… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0627-2021 RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthe… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0626-2021 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone. — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0625-2021 PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fractu… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0624-2021 Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral comp… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0623-2021 OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage. — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0622-2021 M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures. — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0621-2021 Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint dise… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0620-2021 Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical ins… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0619-2021 Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 18… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0618-2021 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 1100… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0617-2021 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 11000… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-11-25 Class II Terminated Z-0616-2021 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790,… — Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d…
2020-09-04 Class II Terminated Z-0084-2021 Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
2020-09-04 Class II Terminated Z-0083-2021 Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
2020-09-04 Class II Terminated Z-0082-2021 Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
2020-09-04 Class II Terminated Z-0081-2021 Biomet Regenerex Primary Taper Cap Item Number 141269 — Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
2020-09-03 Class II Terminated Z-0097-2021 (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: … — Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized tw…
2020-09-02 Class II Terminated Z-0093-2021 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 01000058… — Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be …
2020-05-14 Class II Terminated Z-2324-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intend… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2323-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intend… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2322-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2321-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2320-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2319-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2318-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2317-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intend… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2316-2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2315-2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2314-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usag… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2313-2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usa… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2312-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usa… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2311-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for … — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2310-2020 A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporar… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2309-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended f… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2308-2020 A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary in… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2307-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intend… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2306-2020 A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intende… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2305-2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for te… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2304-2020 Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary inte… — Distributed to the field without having completed design history files or design transfer activities
2020-05-14 Class II Terminated Z-2303-2020 Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for tempora… — Distributed to the field without having completed design history files or design transfer activities
2020-05-11 Class II Terminated Z-2300-2020 Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)0088030482… — The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a …
2020-05-01 Class II Terminated Z-2363-2020 Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 — Device and tray that houses the device did not pass steam sterilization process validation testing
2020-05-01 Class II Terminated Z-2362-2020 Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 — Device and tray that houses the device did not pass steam sterilization process validation testing
2020-04-17 Class II Terminated Z-2156-2020 Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2155-2020 Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US15… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2154-2020 Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee Syste… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2153-2020 Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee Syst… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2152-2020 Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2151-2020 Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, … — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2150-2020 Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial B… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2149-2020 Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS … — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2148-2020 Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Par… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2147-2020 Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2146-2020 Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product … — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2145-2020 Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingL… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-04-17 Class II Terminated Z-2144-2020 Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Hume… — Potential presence of elevated endotoxin levels that exceed the specification limit
2020-03-13 Class II Terminated Z-1750-2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended … — There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
2020-02-26 Class II Terminated Z-1670-2020 BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1669-2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1668-2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1667-2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1666-2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1665-2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1664-2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1663-2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1662-2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1661-2020 BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1660-2020 BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1659-2020 BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1658-2020 BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1657-2020 BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1656-2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1655-2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1654-2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1653-2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1652-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1651-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1650-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1649-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1648-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1647-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1646-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1645-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1644-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1643-2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1642-2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1641-2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1640-2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1639-2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-26 Class II Terminated Z-1638-2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
2020-02-25 Class II Terminated Z-1615-2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or … — Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
2020-02-17 Class II Terminated Z-1543-2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehe… — A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
Filings

All 510(k) clearances (17)

Date K-number Device Code Class Specialty
2026-07-01 K253434 OSSTM Orthopedic Salvage System JDI Class II Orthopedic
2026-05-19 K251270 Taperloc® Complete Hip Stem LPH Class II Orthopedic
2024-05-22 K241014 Biomet Kirschner Wires (K-Wires) HTY Class II Orthopedic
2022-12-28 K222760 StageOne™ Select Hip Cement Spacer Molds MBB Class II Orthopedic
2022-09-15 K221968 StageOne™ Shoulder Cement Spacer Molds MBB Class II Orthopedic
2022-09-02 K213287 StageOne Knee Cement Spacer Molds MBB Class II Orthopedic
2022-02-07 K212431 Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve JDG Class II Orthopedic
2021-12-10 K212435 Comprehensive Humeral Fracture Positioning Sleeves KWS Class II Orthopedic
2021-02-19 K210192 A.L.P.S. Clavicle Plating System HRS Class II Orthopedic
2020-11-10 K193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws MBI Class II Orthopedic
2020-09-25 K193546 Distal Centralizers JDG Class II Orthopedic
2020-04-15 K193373 Comprehensive® Reverse Shoulder PHX Class II Orthopedic
2020-03-05 K193402 ALLthread PEEK Suture Anchor MBI Class II Orthopedic
2020-02-24 K193451 Titanium Interference Screws HWC Class II Orthopedic
2020-02-20 K193533 WIN Flexible Nail System JDS Class II Orthopedic
2020-01-16 K192942 ALLthread Titanium Suture Anchor MBI Class II Orthopedic
2020-01-02 K193092 TunneLoc Tibial Fixation Device MBI Class II Orthopedic
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence