Pega Medical Inc. recalls Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265…

Recall date

June 15, 2015

Source

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

Recall number

Z-1848-2015

FDA classification

Class II

Brand / firm

Pega Medical Inc.

Sold / distributed

US Distribution to the states of : FL and TN.

Why it was recalled

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.

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

What was recalled

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.