Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-0277-2025 · Posted 2024-10-30

Recalling FirmSmith & Nephew Inc
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2024-10-02
Product Quantity3 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.

Firm Action

Smith & Nephew issued an "Urgent Medical Device Recall Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall please contact FieldActions@smith nephew.com.

Root Cause

Packaging change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043440SMITH & NEPHEW, INC. REVISION KNEE SYSTEMSmith & Nephew, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑