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.
Recall
- Recall Number
- Z-0580-2016
- Event Number
- 72727
- Firm
- Corflex
- FEI Number
- 1218997
- Product Code
- ITQ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 12, 2015
- Terminated
- June 29, 2016
- Address
- 669 E Ind Park Dr, Manchester, NH, 03109-5625
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.
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,
Corflex notified customers on November 12, 2015, initially via phone. On December 9, 2015, a follow-up letter dated December 8, 2015, was issued via email with read receipt. Customers have been instructed to return all product to Corflexs Manchester, NH manufacturing facility. This removal includes product that is new, in use and no longer in service. Customers have been provided instructions on how to contact our Customer Service department to initiate the return process and generate a Returns Material Authorization. UPS Call Tags are also being issued to facilitate the return of braces at no cost to the customer. Contact Corflex at [email protected] or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST
Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
80 units