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Medtronic Sofamor Danek USA, Inc recalls Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spina
Recalled June 16, 2021 · FDA recall Z-1797-2021 · Medtronic Sofamor Danek USA
Hazard
Product is impacted by a thread profile defect due to a manufacturing issue. · FDA Class II
Units
162 UNITS
Sold at
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Description
Product is impacted by a thread profile defect due to a manufacturing issue.
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.
Manufacturer(s)
Medtronic Sofamor Danek USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →