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 a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. |
| Product | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of Texas and Michigan. |
| Initiated | 2026-03-19 |
| Classified | 2026-08-06 |
| Recall number | Z-2897-2026 |
| 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-2897-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99025/
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