FDA Device

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

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.

What You Should Do

Remedy

Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: Identify the device with the same catalogue number and lot number Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242.

Products

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Brand
Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
UPC
Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.

Units Affected

4 units