BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1848-2015 · Initiated June 15, 2015

    Recall

    Recall Number
    Z-1848-2015
    Event Number
    71560
    Firm
    Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
    FEI Number
    3000327445
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    June 15, 2015
    Posted
    June 26, 2015
    Terminated
    December 29, 2015

    Description

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

    Reason

    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.

    Action

    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.

    Distribution

    US Distribution to the states of : FL and TN.

    Quantity

    4 units