Device recall
Z-1797-2021: Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended…
FDA device recall · Class II · Medtronic Sofamor Danek USA, Inc
Key facts
| Recall number (Z-number) | Z-1797-2021 |
|---|---|
| Recall event | 87842 |
| Product | 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 code | MRW |
| Recalling firm | Medtronic Sofamor Danek USA, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 20, 2024 |
| FEI number | 3003120897 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database