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United Orthopedic Corp. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog NumClass IIMay 20, 2026Due to an incomplete process of the component screw by a sub |
| Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 Class IIMay 20, 2026Due to an incomplete process of the component screw by a sub |
| Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number:Class IIMay 20, 2026Due to an incomplete process of the component screw by a sub |
| Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus ofClass IIMay 20, 2026Due to an incomplete process of the component screw by a sub |
| Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 SoClass IIMar 19, 2026Due to a design issue causing the incorrect engraved numberi |
| Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 SoClass IIMar 19, 2026Due to a design issue causing the incorrect engraved numberi |