Recall Z-1237-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500
| Date | Jun 3, 2022 (initiated Mar 30, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On March 30, 2022, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately identify, quarantine, and discontinue use of any affected devices in their facility. Customers should return the devices back to Stryker. If you have any questions or concerns regarding this recall, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. ***Updated 6/6/22*** On June 6, 2022, the firm sent an updated letter to affected customers. The update letter inclu |
| Quantity | 22 units (12 US; 10 OUS) |
| Distribution | Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker, May 3, 2013 |