United Orthopedic Corporation recalls U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indica

Recalled March 28, 2018 · FDA recall Z-1129-2018 · United Orthopedic

Hazard

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 Class II

Units

14 pieces

Sold at

Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.

Description

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.

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.

Manufacturer(s)

United Orthopedic Corporation

Made in

Taiwan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →