Smith & Nephew Inc: Device Recall

Recall #Z-0278-2025 · 10/02/2024

Class II: Risk

Recall Details

Recall Number: Z-0278-2025
Classification: Class II
Product Type: Device
Recalling Firm: Smith & Nephew Inc
Status: Ongoing
Date Initiated: 10/02/2024
Location: Memphis, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

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.

Product Description

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

Distribution Pattern

US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.

Other Recalls by Smith & Nephew Inc

Class II: Risk 11/24/2025

Removal of affected lot of screws due to labeling error.
Class II: Risk 03/18/2025

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Class II: Risk 10/29/2024

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class II: Risk 10/15/2024

The Bipolar assembly contains an oversized Retainer Ring.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

View all recalls by Smith & Nephew Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.