Recalls / —

—#46261

Product

Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152

FDA product code

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

05LM01939

Why it was recalled

Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.

Root cause (FDA determination)

Other

Action the firm took

All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.

Recalling firm

Firm

Smith & Nephew Inc

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Worldwide-including states of LA, NC, IN, and countries of France, and Turkey

Timeline

Recall initiated

2006-04-12

Posted by FDA

2006-06-17

Terminated

2007-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #46261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.