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.
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- April 27, 2021
- Terminated
- August 20, 2024
- Recall Number
- Z-1797-2021
- Quantity
- 162 UNITS
- Firm Location
- Memphis, TN
Reason for Recall
Product is impacted by a thread profile defect due to a manufacturing issue.
Distribution
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Lot / Code Info
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
Root Cause
Under Investigation by firm
Action Taken
On 4/26/2021 the firm sent a letter to its consignees with the following instructions: Required Actions: 1) Identify, segregate, and quarantine any impacted product (listed above) within your inventory. 2) Return the impacted product to Medtronic. Your Medtronic Sales Representative can assist in facilitating the return of product as necessary. 3) Please maintain a copy of this notice in your records. 4) Please share this communication within your organization, with other organizations where affected devices have been transferred, and any other associated organizations that may be impacted by this action.