BEUDAMED
    FDA Enforcement Class II 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 · Reported December 2, 2015

    Enforcement

    Recall Number
    Z-0324-2016
    Event ID
    72529
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 2, 2015
    Initiation Date
    October 20, 2015
    Classification Date
    November 20, 2015
    Termination Date
    August 16, 2016
    Address
    1111 Autoroute Chomedy, N/A, Laval, N/A, N/A, Canada

    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.

    Code Info

    Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02

    Distribution

    Distributed in the states of FL and TN.

    Quantity

    4 units distributed in the US