Class 2 Device Recall Knee joint replacement

• Date Initiated by Firm: November 24, 2017
• Create Date: March 19, 2018
• Recall Status: Terminated on October 09, 2018
• Recall Number: Z-1128-2018
• Recall Event ID: 79321
• 510(K)Number: K051640
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
• Code Information: Lot number 17B621AX
• Recalling Firm/ Manufacturer: United Orthopedic Corporation; No. 57 Park Avenue 2, Science Park; Hsinchu Taiwan
• For Additional Information Contact: 949-328-3366
• Manufacturer Reason for Recall: UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
• FDA Determined Cause: Labeling mix-ups
• Action: Urgent Field safety notice was distributed to customers on November 24, 2017 via e-mail. The letter identified the affected product, problem and actions to be taken. For further questions, please call (949) 328-3366.
• Quantity in Commerce: 69 pieces
• Distribution: Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
• 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.

• 510(K) Database: 510(K)s with Product Code = JWH