—#187669

Product

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

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: Lot 20HM17607

Why it was recalled

The device components experienced a manufacturing process error that resulted in surface damage from product handling.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.

Timeline

Recall initiated: 2021-05-19
Terminated: 2023-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187669. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.