Recall Z-0578-2016 ยท ITQ Joint, Knee, External Brace
Corflex
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.
| Date | Nov 12, 2015 |
| Status | Terminated |
| 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, |
| Root cause | Nonconforming Material/Component |
| Action | 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 a |
| Quantity | 10 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.