—#210380

Product

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

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043440
Affected lot / code info: UDI/DI 03596010543820, Batch Number 23LM00479

Why it was 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.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 6409 E Holmes Rd, Memphis, Tennessee 38141-8310

Distribution

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

Timeline

Recall initiated: 2024-10-02
Posted by FDA: 2024-10-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210380. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.