United Orthopedic Corp.
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Lot Code: Product number 9323-5312; UDI-DI 04719886908077; Lot number 25FC64
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →