Recall Z-2883-2026 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
| Date | Aug 5, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| Reason | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Root cause | Process design |
| Action | On 03/11/2026, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that due the fact that the PSA Box Trial cannot be properly assembled with the Hinge Trial in the affected devices because of incomplete processing of the screw components, which may result in interference during assembly with the corresponding device. On 05/20/2026, the firm emailed an updated "URGENT: MEDCIAL DEVICE RECALL" Letter Customers are instructed: 1. Examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. Please note th |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082424 | UNITED U2 TOTAL KNEE SYSTEM United Orthopedic Corp., Dec 16, 2008 |