Z-1797-2021 Class II Terminated
FDA device recall Z-1797-2021 was initiated by Medtronic Sofamor Danek USA, Inc on April 27, 2021 and is designated Class II. Reason for recall: Product is impacted by a thread profile defect due to a manufacturing issue. The recall status is terminated (terminated August 20, 2024). Affected quantity: 162 UNITS.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 27, 2021
- Termination Date
- August 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162 UNITS
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.
Distribution Pattern
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Code Information
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028