Howmedica Osteonics Corp. Recall 94215
Description: TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Howmedica Osteonics Corp. Recall 94215 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1631-2024 |
| Event ID | 94215 |
| Event Description | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F |
| Product Type | Devices |
| Distribution | Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK |
| Recall Reason | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
| Device Classification | 20240501 |
| Device Code Info | UDI-DI: (01)07613327380811(17)290313(10) Lot Number: 13927651 |
| Center Classification Date | 20240425 |
| Recall Initiation Date | 20240227 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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