Reported Jun 16, 2021 · Terminated
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the…
Medtronic Sofamor Danek USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA, Inc · 4340 Swinnea Rd · Memphis, TN · 38118-6603
Is this the product you have?
- Braive Growth Modulation System
- Break-Off Set Screws - Product Usageintended 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
- Lot codes and dates
- CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
- Amount recalled
- 162 UNITS
Why it was recalled
Product is impacted by a thread profile defect due to a manufacturing issue.
This product could cause temporary or reversible health problems — stop using it.
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