Corflex recalls BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of…

Recall date

November 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0578-2016

FDA classification

Class II

Brand / firm

Corflex

Sold / distributed

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

Why it was recalled

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,

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 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.