Recall Z-1128-2018— United Orthopedic Corporation

Name: FDA recall Z-1128-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-24

Class II · Terminated

Class II FDA medical device recall by United Orthopedic Corporation, initiated 2017-11-24, terminated 2018-10-09. It names one FDA 510(k) clearance: K051640. 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.. Reason: 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..

Recalling firm: United Orthopedic Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-24
Terminated: 2018-10-09
Firm location: Hsinchu, N/A, Taiwan

510(k) clearances named in this recall

1 on FDA's record

K051640 — U2 TOTAL KNEE SYSTEMUnited Orthopedic Corp.·cleared 2006-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.