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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