FDA recall, , Moderate risk
United Orthopedic U2 and USTAR II Knee Trial and Instrument Sets
Knee femur prosthesis trials and adaptors may not assemble properly due to an incomplete process of the component screw.
Summary by Recall Canary from the FDA notice
What happened
United Orthopedic Corp. of Kaohsiung, Taiwan, recalled U2 Total Knee System and USTAR II Knee System knee femur prosthesis trials and adaptors due to an incomplete process of the component screw. The FDA added the recall to its Enforcement Report on August 5, 2026. Distribution was 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 your box affected?
4 products
Affected if its UDI-DI, lot code and model/catalog number are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Ustar II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6
- UDI-DI
- 04719886907032
- 04719886907049
- 04719886907056
- 04719886907063
- 04719886907070
- 04719886907087
- 04719886907094
- 04719886907100
- 04719886907117
- 04719886907124
- 04719886907131
- 04719886907148
- Lot code
- 9325-5711
- 25FB41
- 9325-5712
- 25FB42
- 9325-5713
- 25FB43
- 9325-5714
- 25FB44
- 9325-5715
- 25FB45
- 9325-5716
- 25FB46
- 9325-5721
- 25FB35
- 9325-5722
- 25FB36
- 9325-5723
- 25FB37
- 9325-5724
- 25FB38
- 9325-5725
- 25FB39
- 9325-5726
- 25FB40
- Model/Catalog number
- 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726
U2 Total Knee System Femoral valgus adaptor, left and right
- UDI-DI
- 04719886908084
- 04719886908091
- Model/Catalog number
- 9323-5333
- 9323-5334
- Lot code
- 25FB50
- 25FB51
U2 Total Knee System PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6
- UDI-DI
- 04719886906929
- 04719886906936
- 04719886906943
- 04719886906950
- 04719886906967
- 04719886906424
- 04719886906974
- 04719886906981
- 04719886906998
- 04719886907001
- 04719886907018
- 04719886907025
- Lot code
- 9323-5511
- 25FB54
- 9323-5512
- 25FB55
- 9323-5513
- 25FB56
- 9323-5514
- 25FB57
- 9323-5515
- 25FB58
- 9323-5516
- 25FB59
- 9323-5521
- 25FB29
- 9323-5522
- 25FB30
- 9323-5523
- 25FB31
- 9323-5524
- 25FB32
- 9323-5525
- 25FB33
- 9323-5526
- 25FB34
- Model/Catalog number
- 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526
U2 Total Knee System Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right
- UDI-DI
- 04719886906554
- 04719886906578
- 04719886906592
- 04719886906561
- 04719886906585
- 04719886906608
- Model/Catalog number
- 9323-5335
- 9323-5337
- 9323-5339
- 9323-5336
- 9323-5338
- 9323-5340
- Lot code
- 25FB64
- 25FB48
- 25FB52
- 25FB65
- 25FB49
- 25FB53
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
- 99026
- Recall numbers
- Z-2883-2026 to Z-2886-2026
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
