Corflex: Medical Device Recall in 2016 - (Recall #: Z-0575-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 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. 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.

Product Classification:

Class II

Date Initiated: November 12, 2015

Date Posted: January 13, 2016

Recall Number: Z-0575-2016

Event ID: 72727

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,

Status: Terminated

Product Quantity: 6 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated