Braive Growth Modulation System Break-Off Set Screws recall
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide…
Why was Braive Growth Modulation System Break-Off Set Screws recalled?
Product is impacted by a thread profile defect due to a manufacturing issue.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
- Product
- Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide…
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Quantity
- 162 UNITS
- Distribution
- International distribution in the countries of France, Switzerland and Jordan. No US distribution.
- Recall date
- June 16, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)