Z-0574-2016 Class II Terminated
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
- 1,406 units
Product Description
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 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