Pega Medical Inc. recalls SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This ins…

Recall date

October 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0324-2016

FDA classification

Class II

Brand / firm

Pega Medical Inc.

Sold / distributed

Distributed in the states of FL and TN.

Why it was recalled

SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.