CLASS II Device recall · Reported 16 Jun 2021 · FDA Enforcement Report
Braive Growth Modulation System Break-Off Set Screws recalled
Medtronic Sofamor Danek USA is recalling Braive Growth Modulation System Break-Off Set Screws, distributed nationwide in the US. The recall was initiated on 27 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1797-2021
- FDA event ID
- 87842
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2021
- FDA classified
- 4 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 27 Apr 2021 | Recall initiated by company | |
| 4 Jun 2021 | Classified by FDA | +38 days |
| 16 Jun 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is impacted by a thread profile defect due to a manufacturing issue.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Questions about this recall
Why was it recalled?
Product is impacted by a thread profile defect due to a manufacturing issue.
Which lots are affected?
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
Where was it sold?
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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