Medtronic Sofamor Danek USA, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medtronic Sofamor Danek USA, Inc
Lot Codes / Batch Numbers
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
Products Sold
CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
Medtronic Sofamor Danek USA, Inc is recalling Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further prog due to Product is impacted by a thread profile defect due to a manufacturing issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is impacted by a thread profile defect due to a manufacturing issue.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026