United Orthopedic Corp.: Counter, Sponge, Surgical
- Recalling firm
- United Orthopedic Corp.
- 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
- Reason
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of Texas and Michigan.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ff2998c7-f445-4e59-b7d2-7315264512f7