Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Braive Growth Modulation System Break-Off Set Screws - Product Usage: Recalled by Medtronic Sofamor Danek USA, Inc Due to Product is impacted by a thread profile defect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA, Inc directly.
Affected Products
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.
Quantity: 162 UNITS
Why Was This Recalled?
Product is impacted by a thread profile defect due to a manufacturing issue.
Where Was This Sold?
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
About Medtronic Sofamor Danek USA, Inc
Medtronic Sofamor Danek USA, Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report