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U.S. Department of Health and Human Services

Class 2 Device Recall Knee joint replacement

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  Class 2 Device Recall Knee joint replacement see related information
Date Initiated by Firm November 24, 2017
Create Date March 19, 2018
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-1129-2018
Recall Event ID 79321
510(K)Number K082424  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016

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 17B621AG
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 2		 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 14 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 and Original Applicant = UNITED ORTHOPEDIC CORP.
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