Recall Z-0580-2016— Corflex
Class II · Terminated
Class II FDA medical device recall by Corflex, initiated 2015-11-12, terminated 2016-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 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,.
- Recalling firm
- Corflex
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-12
- Terminated
- 2016-06-29
- Firm location
- Manchester, NH, United States
Product description
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 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,
Data sourced from openFDA. This site is unofficial and independent of the FDA.