Medtronic Sofamor Danek USA, Inc Recall 87842
Description: Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Medtronic Sofamor Danek USA, Inc Recall 87842 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1797-2021 |
| Event ID | 87842 |
| Event Description | Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve. |
| Product Type | Devices |
| Distribution | International distribution in the countries of France, Switzerland and Jordan. No US distribution. |
| Quantity | 162 UNITS |
| Recall Reason | Product is impacted by a thread profile defect due to a manufacturing issue. |
| Device Classification | 20210616 |
| Device Code Info | CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028 |
| Center Classification Date | 20210604 |
| Recall Initiation Date | 20210427 |
| Recalling Firm | Medtronic Sofamor Danek USA, Inc |
| Initial Notification | Letter |
| Similar To |