—#187226

Product

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.

FDA product code: MRW — System, Facet Screw Spinal Device
Device class: Class U
Medical specialty: Unknown
Affected lot / code info: CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028

Why it was recalled

Product is impacted by a thread profile defect due to a manufacturing issue.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA, Inc
Address: 4340 Swinnea Rd, Memphis, Tennessee 38118-6603

Distribution

Distribution pattern: International distribution in the countries of France, Switzerland and Jordan. No US distribution.

Timeline

Recall initiated: 2021-04-27
Terminated: 2024-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187226. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.