Home / Recalls / Corflex / Z-0578-2016

Z-0578-2016 Class II Terminated

Recalled by Corflex — Manchester, NH

Recall Details

Product Type: Devices
Report Date: January 13, 2016
Initiation Date: November 12, 2015
Termination Date: June 29, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 units

Product Description

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.

Reason for Recall

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,

Distribution Pattern

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

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

Other recalls by Corflex

Z-0574-2016 Class II — Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Kn (November 12, 2015)
Z-0576-2016 Class II — HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative K (November 12, 2015)
Z-0577-2016 Class II — ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Opera (November 12, 2015)
Z-0575-2016 Class II — CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operativ (November 12, 2015)
Z-0580-2016 Class II — CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee (November 12, 2015)
Z-0579-2016 Class II — ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative (November 12, 2015)