RecallRadar

FDA Device recall 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…

On 2016-01-13 the FDA classified a Class II recall of 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… by Corflex, citing 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,.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0574-2016
ClassificationClass II
Statusterminated
Initiated2015-11-12
Published2016-01-13
Last updated2026-09-13 11:54 UTC
CompanyCorflex
DistributionUS

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.

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,

Identifiers

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…(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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0574-2016%22

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