FDA Medical devices recall ·
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT… recall
- Recall number
- Z-0277-2025
- Date
- (initiated October 2, 2024)
- Company / brand
- Smith & Nephew, Inc.
6409 E Holmes Rd, Memphis, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 03596010543820, Batch Number 23LM00479
Distribution
US Distribution to state of Texas and OUS (foreign) to countries of: Spain, France and United Kingdom,.
States: Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0277-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.