Recall Z-1797-2021— Medtronic Sofamor Danek USA, Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA, Inc, initiated 2021-04-27, terminated 2024-08-20. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-27
- Terminated
- 2024-08-20
- Firm location
- Memphis, TN, United States
Product 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.
Reason for recall
Product is impacted by a thread profile defect due to a manufacturing issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.