FDA Device

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 con

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.

What You Should Do

Remedy

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.

Products

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 i
Brand
United Orthopedic Corporation No.
UPC
Lot number 17B621AX

Units Affected

69 pieces