FDA recall, , Moderate risk
U2 Total Knee System Femoral Offset Bushings
Femoral offset bushings have incorrect engraved numbering that could cause incorrect implant orientation.
Summary by Recall Canary from the FDA notice
What happened
United Orthopedic Corp. of Kaohsiung, Taiwan, recalled its Femoral offset bushing products for the U2 Total Knee System due to a design issue causing incorrect engraved numbering on the implant, which could result in the incorrect orientation of the implant. The recall affects the Femoral offset bushing, 0mm and 4mm, model 9323-5310, and the Femoral offset bushing, 2mm and 6mm, model 9323-5312.
The company began the recall on March 19, 2026, and it was added to the FDA's Enforcement Report on August 6, 2026. Distribution was nationwide in the states of Texas and Michigan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
U2 Total Knee System Femoral offset bushing, 0mm and 4mm
- UDI-DI
- 04719886908060
- Model/Catalog number
- 9323-5310
- Lot code
- 25FC58
U2 Total Knee System Femoral offset bushing, 2mm and 6mm
- UDI-DI
- 04719886908077
- Model/Catalog number
- 9323-5312
- Lot code
- 25FC64
Recall details
- Company began the recall
- Company
- United Orthopedic Corp.Kaohsiung, Taiwan
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99025
- Recall numbers
- Z-2897-2026 to Z-2898-2026
All recalls from United Orthopedic Corp.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
