BEUDAMED
    FDA Enforcement Class II 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 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1848-2015
    Event ID
    71560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pega Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2015
    Initiation Date
    June 15, 2015
    Classification Date
    June 26, 2015
    Termination Date
    December 29, 2015
    Address
    1111 Autoroute Chomedy, Laval, N/A, Canada

    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.

    Code Info

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

    Distribution

    US Distribution to the states of : FL and TN.

    Quantity

    4 units