BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0324-2016 · Initiated October 20, 2015

    Recall

    Recall Number
    Z-0324-2016
    Event Number
    72529
    Firm
    Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
    FEI Number
    3000327445
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 20, 2015
    Posted
    November 20, 2015
    Terminated
    August 16, 2016

    Description

    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.

    Reason

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

    Action

    The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm. Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to [email protected]

    Distribution

    Distributed in the states of FL and TN.

    Quantity

    4 units distributed in the US