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FDAOctober 2, 2024device

smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

What to do

FDA enforcement status: Ongoing

Brands named

smith nephewsmithsmith nephew

UPCs

03596010543820

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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