PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 8, 2015 Initiated: June 15, 2015 #Z-1848-2015

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Pega Medical Inc.
Units Affected
4 units
Distribution
US Distribution to the states of : FL and TN.
Location
Laval

Frequently Asked Questions

What product was recalled?
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.. Recalled by Pega Medical Inc.. Units affected: 4 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1848-2015.