Howmedica Osteonics Corp. Recall 92257
Description: TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Howmedica Osteonics Corp. Recall 92257 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1654-2023 |
| Event ID | 92257 |
| Event Description | TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan |
| Quantity | 24 units in total |
| Recall Reason | 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 TIBIAL BEARING INSERT PS #4 13MM, and vice versa |
| Device Classification | 20230607 |
| Device Code Info | GTIN: 07613327338560 Lot Number: 7H8RPL |
| Center Classification Date | 20230530 |
| Recall Initiation Date | 20230413 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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