| 2026-05-20 |
Class II
|
Ongoing |
Z-2531-2026 |
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 |
— |
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 |
Class II
|
Ongoing |
Z-2530-2026 |
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 |
— |
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 |
Class II
|
Ongoing |
Z-2529-2026 |
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242 |
— |
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 |
Class II
|
Ongoing |
Z-2528-2026 |
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 |
— |
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-05-20 |
Class II
|
Ongoing |
Z-2527-2026 |
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 |
— |
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| 2026-03-30 |
Class II
|
Ongoing |
Z-1946-2026 |
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-0… |
— |
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeli… |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0983-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0982-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0981-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0980-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0979-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0978-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0977-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0976-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0975-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0974-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0973-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0972-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0971-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0970-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0969-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0968-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-12-02 |
Class II
|
Ongoing |
Z-0967-2026 |
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:… |
— |
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant … |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0419-2026 |
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Ca… |
— |
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as… |
| 2025-09-26 |
Class II
|
Ongoing |
Z-0418-2026 |
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca… |
— |
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1649-2025 |
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained… |
— |
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome f… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1648-2025 |
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained… |
— |
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome f… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1647-2025 |
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained… |
— |
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome f… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1646-2025 |
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constr… |
— |
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome f… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1645-2025 |
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr… |
— |
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome f… |
| 2025-02-27 |
Class II
|
Ongoing |
Z-1433-2025 |
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number… |
— |
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the trans… |
| 2025-02-12 |
Class II
|
Ongoing |
Z-1329-2025 |
Z1 Femoral Hip System, Product Number 611777612 |
— |
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip. |
| 2025-01-06 |
Class II
|
Ongoing |
Z-1039-2025 |
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10 |
— |
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly… |
| 2025-01-06 |
Class II
|
Ongoing |
Z-1038-2025 |
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 |
— |
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly… |
| 2024-09-17 |
Class II
|
Ongoing |
Z-0285-2025 |
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo… |
— |
A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. Thi… |
| 2024-08-08 |
Class II
|
Ongoing |
Z-3133-2024 |
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce… |
— |
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck slee… |
| 2024-08-08 |
Class II
|
Ongoing |
Z-3132-2024 |
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or no… |
— |
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck slee… |
| 2024-07-02 |
Class II
|
Ongoing |
Z-2450-2024 |
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00… |
— |
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| 2024-03-28 |
Class II
|
Ongoing |
Z-1608-2024 |
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. |
— |
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad t… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1729-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stab… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1728-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabi… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1727-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stab… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1726-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabi… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1725-2024 |
ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and st… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1724-2024 |
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1723-2024 |
ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and sta… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1722-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indic… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1721-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicate… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1720-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabil… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1719-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicat… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1718-2024 |
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicate… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1717-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1716-2024 |
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1715-2024 |
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabiliz… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1714-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicat… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1713-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicat… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1712-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicat… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1711-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicate… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1710-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicat… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1709-2024 |
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated… |
— |
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recogniza… |
| 2023-07-26 |
Class II
|
Ongoing |
Z-2519-2023 |
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number … |
— |
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. |
| 2023-06-27 |
Class II
|
Ongoing |
Z-2254-2023 |
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary int… |
— |
Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recogniz… |
| 2023-05-19 |
Class II
|
Ongoing |
Z-2092-2023 |
NexGen Precoat Stemmed Tibial Plate Size 5 |
— |
Device outer packaging was incorrectly labeled. |
| 2023-02-27 |
Class II
|
Ongoing |
Z-1294-2023 |
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip … |
— |
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasu… |
| 2022-12-07 |
Class II
|
Ongoing |
Z-1098-2023 |
Identity Shoulder System Resection Planer 35mm Resection Planer |
— |
Two planers were found to be unusable during sawbones shoulder training. |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0471-2023 |
NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0470-2023 |
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0469-2023 |
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0468-2023 |
NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0467-2023 |
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-12-06 |
Class II
|
Ongoing |
Z-0466-2023 |
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 |
— |
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically sig… |
| 2022-08-25 |
Class II
|
Ongoing |
Z-0007-2023 |
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip… |
— |
The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Poten… |
| 2021-05-07 |
Class II
|
Terminated |
Z-1793-2021 |
Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temp… |
— |
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree |
| 2021-05-07 |
Class II
|
Terminated |
Z-1792-2021 |
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for tempor… |
— |
Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree |