Howmedica Osteonics Corp. Recall 90241
Description: Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
Howmedica Osteonics Corp. Recall 90241 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1237-2022 |
| Event ID | 90241 |
| Event Description | Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500 |
| Product Type | Devices |
| 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. |
| Quantity | 22 units (12 US; 10 OUS) |
| Recall 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. |
| Device Classification | 20220615 |
| Device Code Info | Catalog Number UDI-DI (GTIN) Lots 5536-B-600 07613327041514 CTD69463 5536-B-500 07613327041507 CTD69106 |
| Center Classification Date | 20220603 |
| Recall Initiation Date | 20220330 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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