FDAFDA · Food and drugs·Recall number Z-0574-2016
Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 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.
Published January 13, 2016 · Recall initiated: November 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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,
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Corflex
- Distributor
- Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
- Lot
- (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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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