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Recall Observatory FDA recall evidence

Device product

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.

Z-0574-2016

November 12, 2015

Class II

Product summary

Firm
Corflex
Event
Event 72727
Status
Terminated
Classification
Class II
Quantity
1,406 units
Official record key
device-enforcement:Z-0574-2016

Official wording

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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,