BEUDAMED
    FDA Enforcement Class II Terminated

    CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    Recall: Z-0580-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0580-2016
    Event ID
    72727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Corflex
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 12, 2015
    Classification Date
    January 4, 2016
    Termination Date
    June 29, 2016
    Address
    669 E Ind Park Dr, N/A, Manchester, NH, 03109-5625, United States

    Description

    CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

    Reason

    Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,

    Code Info

    (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

    Quantity

    80 units