| 2026-05-19 |
Class II
|
Ongoing |
Z-2462-2026 |
TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. |
— |
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TY… |
| 2026-05-19 |
Class II
|
Ongoing |
Z-2461-2026 |
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. |
— |
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TY… |
| 2026-02-02 |
Class II
|
Ongoing |
Z-1572-2026 |
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 |
— |
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cov… |
| 2025-11-12 |
Class II
|
Ongoing |
Z-0963-2026 |
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr… |
— |
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application… |
| 2025-08-28 |
Class II
|
Ongoing |
Z-2640-2025 |
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0… |
— |
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa.… |
| 2024-09-04 |
Class II
|
Ongoing |
Z-0023-2025 |
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur… |
— |
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the lock… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-0044-2025 |
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 |
— |
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. |
| 2024-08-05 |
Class II
|
Ongoing |
Z-2732-2024 |
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100… |
— |
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| 2024-06-19 |
Class II
|
Ongoing |
Z-2372-2024 |
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: … |
— |
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product… |
| 2024-06-19 |
Class II
|
Ongoing |
Z-2371-2024 |
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: … |
— |
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product… |
| 2024-06-19 |
Class II
|
Ongoing |
Z-2370-2024 |
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: … |
— |
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product… |
| 2024-05-23 |
Class II
|
Ongoing |
Z-2153-2024 |
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 |
— |
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead … |
| 2024-05-23 |
Class II
|
Ongoing |
Z-2152-2024 |
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 |
— |
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead… |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1632-2024 |
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1631-2024 |
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Cata… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1630-2024 |
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1629-2024 |
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1628-2024 |
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1627-2024 |
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog … |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1626-2024 |
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1625-2024 |
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog … |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1624-2024 |
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1623-2024 |
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1622-2024 |
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu… |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-27 |
Class II
|
Ongoing |
Z-1621-2024 |
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog … |
— |
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1266-2024 |
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1265-2024 |
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1264-2024 |
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1263-2024 |
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1262-2024 |
X3 TRIATHLON CS INSERT NO 7 9 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1261-2024 |
X3 TRIATHLON CS INSERT NO 6 11 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1260-2024 |
X3 TRIATHLON CS INSERT NO 6 10 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2024-02-06 |
Class II
|
Ongoing |
Z-1259-2024 |
X3 TRIATHLON CS INSERT NO 3 10 MM |
— |
Potential packaging breaches of inner blister and outer sterile blister. |
| 2023-12-22 |
Class II
|
Ongoing |
Z-1000-2024 |
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip … |
— |
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier In… |
| 2023-12-22 |
Class II
|
Ongoing |
Z-0999-2024 |
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip art… |
— |
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier In… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0926-2024 |
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0925-2024 |
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0924-2024 |
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0923-2024 |
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0922-2024 |
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0921-2024 |
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0920-2024 |
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0919-2024 |
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0918-2024 |
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0917-2024 |
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0916-2024 |
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0915-2024 |
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0914-2024 |
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0913-2024 |
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0912-2024 |
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0911-2024 |
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0910-2024 |
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0909-2024 |
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0908-2024 |
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0907-2024 |
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0906-2024 |
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0905-2024 |
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0904-2024 |
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0903-2024 |
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0902-2024 |
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0901-2024 |
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0900-2024 |
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0899-2024 |
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0898-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0897-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0896-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0895-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0894-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0893-2024 |
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0892-2024 |
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0891-2024 |
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0890-2024 |
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0889-2024 |
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0888-2024 |
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0887-2024 |
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0886-2024 |
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0885-2024 |
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0884-2024 |
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0883-2024 |
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0882-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0881-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0880-2024 |
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0879-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0878-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0877-2024 |
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0876-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0875-2024 |
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0874-2024 |
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0873-2024 |
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0872-2024 |
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0871-2024 |
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0870-2024 |
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0869-2024 |
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 |
— |
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impac… |
| 2023-05-03 |
Class II
|
Ongoing |
Z-1921-2023 |
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 |
— |
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Tria… |
| 2023-04-13 |
Class II
|
Ongoing |
Z-1654-2023 |
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E |
— |
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIA… |
| 2023-04-13 |
Class II
|
Ongoing |
Z-1653-2023 |
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E |
— |
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIA… |
| 2023-03-10 |
Class II
|
Ongoing |
Z-1386-2023 |
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty su… |
— |
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| 2023-03-10 |
Class II
|
Ongoing |
Z-1385-2023 |
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty su… |
— |
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| 2022-11-07 |
Class III
|
Ongoing |
Z-0737-2023 |
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Cata… |
— |
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all conten… |
| 2022-11-07 |
Class III
|
Ongoing |
Z-0736-2023 |
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Cata… |
— |
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all conten… |
| 2022-10-21 |
Class II
|
Ongoing |
Z-0240-2023 |
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010 |
— |
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-0… |
| 2022-08-24 |
Class II
|
Ongoing |
Z-1778-2022 |
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. |
— |
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. T… |
| 2022-03-30 |
Class II
|
Ongoing |
Z-1237-2022 |
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5… |
— |
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling… |
| 2022-01-14 |
Class II
|
Ongoing |
Z-0843-2022 |
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 |
— |
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling |
| 2022-01-14 |
Class II
|
Ongoing |
Z-0842-2022 |
Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 |
— |
Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling |
| 2021-12-30 |
Class II
|
Terminated |
Z-0652-2022 |
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 |
— |
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| 2021-12-30 |
Class II
|
Terminated |
Z-0651-2022 |
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 |
— |
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| 2021-12-21 |
Class II
|
Ongoing |
Z-0645-2022 |
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 |
— |
There is a potential for the outer Tyvek lid to de-bond from the sealed package. |
| 2021-12-21 |
Class II
|
Ongoing |
Z-0644-2022 |
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 |
— |
There is a potential for the outer Tyvek lid to de-bond from the sealed package. |
| 2021-11-24 |
Class II
|
Ongoing |
Z-0459-2022 |
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for steriliz… |
— |
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemen… |
| 2021-10-15 |
Class II
|
Ongoing |
Z-0314-2022 |
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 |
— |
There is a potential for the outer white Tyvek lid to debond from the sealed package. |
| 2021-10-15 |
Class II
|
Ongoing |
Z-0313-2022 |
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 |
— |
XXX |
| 2021-07-01 |
Class II
|
Terminated |
Z-2329-2021 |
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 |
— |
The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of th… |
| 2021-03-05 |
Class II
|
Terminated |
Z-1379-2021 |
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, p… |
— |
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut… |
| 2021-02-10 |
Class II
|
Terminated |
Z-1186-2021 |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. |
— |
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturi… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2099-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2098-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2097-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2096-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2095-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2094-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2093-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2092-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2091-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2090-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2089-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2088-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2087-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2086-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2085-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)0… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-16 |
Class II
|
Terminated |
Z-2084-2020 |
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07… |
— |
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating d… |
| 2020-04-01 |
Class II
|
Terminated |
Z-1900-2020 |
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 |
— |
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis an… |