FDA-Device2015-12-02Class II
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Pega Medical Inc.
Hazard
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Sold states
Distributed in the states of FL and TN.
Affected count
4 units distributed in the US
Manufactured in
1111 Autoroute Chomedy, N/A, Laval, N/A, Canada
Products
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2016Don't want to check this manually?
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