—#210382

Product

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K962557
Affected lot / code info: UDI/DI 03596010469212, Batch number 23LM02331

Why it was recalled

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.

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. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 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 states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada

Timeline

Recall initiated: 2024-10-02
Posted by FDA: 2024-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210382. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.