# FDA recall Z-1128-2018 > **United Orthopedic Corporation** · Class II · device recall initiated 2017-11-24. ## 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 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 Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa. ## Key facts - **Recall number:** Z-1128-2018 - **Recalling firm:** United Orthopedic Corporation - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2017-11-24 - **Report date:** 2018-03-28 - **Termination date:** 2018-10-09 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Hsinchu, N/A, Taiwan ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2018 ## Citation > AI Analytics. FDA recall Z-1128-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1128-2018. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*