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Pega Medical Inc. recalls SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This
Recalled December 2, 2015 · FDA recall Z-0324-2016 · Pega Medical
Hazard
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. · FDA Class II
Units
4 units distributed in the US
Sold at
Distributed in the states of FL and TN.
Description
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Product
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.
Manufacturer(s)
Pega Medical Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →