BEUDAMED
    FDA Recall Terminated

    CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 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. 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-0575-2016 · Initiated November 12, 2015

    Recall

    Recall Number
    Z-0575-2016
    Event Number
    72727
    Firm
    Corflex
    FEI Number
    1218997
    Product Code
    ITQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 12, 2015
    Terminated
    June 29, 2016
    Address
    669 E Ind Park Dr, Manchester, NH, 03109-5625

    Description

    CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 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. 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,

    Action

    Corflex notified customers on November 12, 2015, initially via phone. On December 9, 2015, a follow-up letter dated December 8, 2015, was issued via email with read receipt. Customers have been instructed to return all product to Corflexs Manchester, NH manufacturing facility. This removal includes product that is new, in use and no longer in service. Customers have been provided instructions on how to contact our Customer Service department to initiate the return process and generate a Returns Material Authorization. UPS Call Tags are also being issued to facilitate the return of braces at no cost to the customer. Contact Corflex at [email protected] or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST

    Distribution

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

    Quantity

    6 units