Moderate riskFDA DeviceAug 12, 2026Class II

United Orthopedic U2 Total Knee adaptor recalled over screw defect

United Orthopedic Corp. is recalling two U2 Total Knee System femoral valgus adaptors (left and right). A subcontractor did not fully complete the process on a component screw, which can prevent the stem trail from being assembled properly. The recall covers model 9323-5333 and 9323-5334 and was distributed in Texas and Michigan. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

Check whether your facility has model 9323-5333 (lot 25FB50) or 9323-5334 (lot 25FB51) femoral valgus adaptors.
Do not use the affected adaptors until you have confirmed the next steps with the manufacturer.
Contact United Orthopedic Corp. for instructions on returning or replacing affected units.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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 Product Description: Manual Orthopedic Surgical Instrument Component: No
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-2885-2026

In the FDA's words

Description: 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 Product Description: Manual Orthopedic Surgical Instrument Component: No 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 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51 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…
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… (this page)
Z-2885-2026 · 2