medical Class II Updated 2021-06-16

Medtronic Sofamor Danek USA, Inc recalls Braive Growth Modulation System Break-Off Set Screws - Produ

Recalled 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.

Hazard / Issue

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

Issued by

FDA

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
View official government recall

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