Recall Z-1128-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
United Orthopedic Corporation
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
| Date | Nov 24, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 69 pieces |
| Distribution | Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051640 | U2 TOTAL KNEE SYSTEM United Orthopedic Corp., Mar 1, 2006 |