FDA-Device2015-07-08Class II
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Pega Medical Inc.
Hazard
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Sold states
US Distribution to the states of : FL and TN.
Affected count
4 units
Manufactured in
1111 Autoroute Chomedy, Laval, Canada
Products
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1848-2015Don't want to check this manually?
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