FDA-Device2021-06-16Class II
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.
Medtronic Sofamor Danek USA, Inc
Hazard
Product is impacted by a thread profile defect due to a manufacturing issue.
Sold states
International distribution in the countries of France, Switzerland and Jordan. No US distribution.
Affected count
162 UNITS
Manufactured in
4340 Swinnea Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief