Class 2 Device Recall Contender Postop Knee Brace Lite

• Date Initiated by Firm: November 12, 2015
• Create Date: January 04, 2016
• Recall Status: Terminated on June 29, 2016
• Recall Number: Z-0578-2016
• Recall Event ID: 72727
• Product Classification: Joint, knee, external brace - Product Code ITQ
• Product: 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.
• 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
• Recalling Firm/ Manufacturer: Corflex; 669 E Ind Park Dr; Manchester NH 03109-5625
• For Additional Information Contact: 603-623-3344
• Manufacturer 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,
• FDA Determined 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 at no cost to the customer. Contact Corflex at service@corflex.com or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST
• Quantity in Commerce: 10 units
• Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.