Z-1129-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 24, 2017
- Termination Date
- October 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 pieces
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
Code Information
Lot number 17B621AG