—#203158

Product

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K112941, K230653
Affected lot / code info: UDI/DI: 00885556234006, Lot Number: 23EM09878

Why it was recalled

The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product.

Recalling firm

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

Distribution

Distribution pattern: OH, CT, TX, NC, CA, NE, NV

Timeline

Recall initiated: 2023-08-31
Posted by FDA: 2023-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203158. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.