Recalls / —

—#34554

Product

P.F.C. Knee System 7 Fluted Femoral Stem 18mmX130mm REF: 96-1731

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

Affected lot / code info

Lot Number: 226287R

Why it was recalled

The collar was incorrectly etched for the R (right) and L (Left) orientation

Root cause (FDA determination)

Other

Action the firm took

Depuy notified distributors at the various territories via verbal contact on 12/23/2003

Recalling firm

Firm

Depuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

NY

Timeline

Recall initiated

2003-12-22

Posted by FDA

2004-08-24

Terminated

2004-09-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.