XTANT Medical Holdings, Inc Recall 93738
Description: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
XTANT Medical Holdings, Inc Recall 93738 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0846-2024 |
| Event ID | 93738 |
| Event Description | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. |
| Product Type | Devices |
| Distribution | US distribution in MI. |
| Quantity | 6 |
| Recall Reason | Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging. |
| Device Classification | 20240207 |
| Device Code Info | UDI-DI: 00810076564005, Lot: AP23000143 |
| Center Classification Date | 20240129 |
| Recall Initiation Date | 20231128 |
| Recalling Firm | XTANT Medical Holdings, Inc |
| Initial Notification | Letter |
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