FDA Device recall Z-2898-2026
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Pr…
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Pr… by United Orthopedic, citing due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2898-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | United Orthopedic |
| Distribution | US |
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Reason
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Identifiers
| code_info | Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2898-2026%22
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