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Terminated

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 Recall Z-1797-2021 · Posted None

Recalling FirmMedtronic Sofamor Danek USA, Inc
Recall StatusTerminated
Product CodeMRW
Date Initiated2021-04-27
Date Terminated2024-08-20
Product Quantity162 UNITS

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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