BEUDAMED
    FDA Enforcement Class II Terminated

    Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

    Recall: Z-0408-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0408-2014
    Event ID
    66412
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    November 26, 2013
    Termination Date
    June 1, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

    Reason

    There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

    Code Info

    Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691

    Distribution

    USA Nationwide Distribution

    Quantity

    166