United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: PSA Box Trial

Recalling company

United Orthopedic Corp.

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

Reason

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 20, 2026

Reported

Aug 12, 2026

Distribution

US Nationwide distribution in the states of Texas and Michigan.

Status

Ongoing

Quantity

2

Lot / codes

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

Company location

Kaohsiung

Recall type

Voluntary: Firm initiated

Recall number

Z-2883-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2883-2026 in the FDA Enforcement Report. Also see FDA recall press releases.