Recall Z-0278-2025— Smith & Nephew Inc

Name: FDA recall Z-0278-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2024-10-02. It names one FDA 510(k) clearance: K043440. Product: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. Reason: 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..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-10-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K043440 — SMITH & NEPHEW, INC. REVISION KNEE SYSTEMSmith & Nephew, Inc.·cleared 2005-02-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.