Medtronic Sofamor Danek USA, Inc: Medical Device Recall in 2021 - (Recall #: Z-1797-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 27, 2021

Date Posted: June 16, 2021

Recall Number: Z-1797-2021

Event ID: 87842

Reason for Recall:

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

Status: Terminated

Product Quantity: 162 UNITS

Code Information:

CT20L012 and CT20L020. CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated