Howmedica Osteonics Corp. Recall 95114
Description: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Howmedica Osteonics Corp. Recall 95114 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2732-2024 |
| Event ID | 95114 |
| Event Description | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; |
| Product Type | Devices |
| Distribution | International distribution to the country of Australia. |
| Quantity | 1 unit (OUS only) |
| Recall Reason | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| Device Classification | 20240904 |
| Device Code Info | Catalog Number: C-MM100434-00; Lot Number: HX2H9A; |
| Center Classification Date | 20240826 |
| Recall Initiation Date | 20240805 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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