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.
Reported: June 16, 2021 Initiated: April 27, 2021 #Z-1797-2021
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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA, Inc
- Units Affected
- 162 UNITS
- Distribution
- International distribution in the countries of France, Switzerland and Jordan. No US distribution.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Sofamor Danek USA, Inc. Units affected: 162 UNITS.
Why was this product recalled? ▼
Product is impacted by a thread profile defect due to a manufacturing issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Moderate. Recall number: Z-1797-2021.
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