Moderate riskFDA DeviceAug 12, 2026Class II

U2 Total Knee System PSA box trial recalled over assembly defect

United Orthopedic Corp. is recalling certain U2 Total Knee System PSA Box Trial knee femur prosthesis trials. A subcontractor did not fully complete a screw on the component, which can prevent the stem trial from being assembled properly. No injuries have been reported, and the devices were distributed in Texas and Michigan.

From the FDA notice · Read the official notice ↗

What to do

Check whether your facility has PSA Box Trial products with the affected catalog numbers and lot codes listed in the recall notice.
Do not use affected trial components until you have confirmed the next steps with the manufacturer.
Contact United Orthopedic Corp. for instructions on returning or replacing affected products.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 2
Illnesses reported: None reported
Manufactured in: No. 16 Luke 1st Rd., Luzhu Dist., Kaohsiung, Taiwan
Classification: Class II
Recall number: Z-2883-2026

In the FDA's words

Description: Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34 Distribution: US Nationwide distribution in the states of Texas and Michigan. Affected quantity: 2
Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

2 products in this recall

U2 Total Knee System trial parts recalled for assembly defect

United Orthopedic is recalling two U2 Total Knee System surgical trial parts: the PSA Box Trial (left and right, sizes 1-6) and the Femoral valgus adaptor (left and right). A subcontractor did not fully finish a screw, so the trial stem cannot be assembled properly. The products were distributed nationwide, with confirmed distribution in Texas and Michigan. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-55… (this page)
Z-2883-2026 · 2
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A…
Z-2885-2026 · 2