FDA Device recall Z-1797-2021
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and pro…
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and pro… by Medtronic Sofamor Danek Usa, citing product is impacted by a thread profile defect due to a manufacturing issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1797-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-27 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
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.
Reason
Product is impacted by a thread profile defect due to a manufacturing issue.
Identifiers
| code_info | CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2021%22
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