Osteomed, LLC Recall 92479
Description: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Osteomed, LLC Recall 92479 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2107-2023 |
| Event ID | 92479 |
| Event Description | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG. |
| Quantity | N/A |
| Recall Reason | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| Device Classification | 20230719 |
| Device Code Info | Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258 |
| Center Classification Date | 20230707 |
| Recall Initiation Date | 20230531 |
| Recalling Firm | Osteomed, LLC |
| Initial Notification | Letter |
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