Recalls / —

—#48459

Product

Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.

FDA product code

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

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K961685

Affected lot / code info

Lot 2203528.

Why it was recalled

Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

Root cause (FDA determination)

Other

Action the firm took

The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.

Recalling firm

Firm

Depuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-09-14

Posted by FDA

2006-10-21

Terminated

2007-04-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #48459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.