Class II — United Orthopedic Corp.
| Recalling firm | UNITED ORTHOPEDIC CORPORATION |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| Product | 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 |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| Initiated | 2026-05-20 |
| Classified | 2026-08-05 |
| Recall number | Z-2884-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — United Orthopedic Corp. (Z-2884-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99026/
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