Braive Growth Modulation System Break-Off Set Screws — Class II medical device recall Z-1797-2021
Terminated recall by Medtronic Sofamor Danek USA, Inc, reported 2021-06-16. Product is impacted by a thread profile defect due to a manufacturing issue.
| Recall number | Z-1797-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA, Inc, Memphis, TN, United States |
| Recall initiated | 2021-04-27 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2024-08-20 |
| Countries outside the US | CH, FR, JO |
| Quantity | 162 units |
| Expiration dates | 2028-12-02, 2028-12-11 |
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 for recall
Product is impacted by a thread profile defect due to a manufacturing issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1797-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.