Recall Z-2884-2026 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
United Orthopedic Corp.
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 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
| K190100 | USTAR II System United Orthopedic Corporation, Sep 23, 2019 |