Events

Recall of Device Recall DePuy Orthopedics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Depuy Orthopaedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29314
  • Event Risk Class
    Class 3
  • Event Number
    Z-1369-04
  • Event Initiated Date
    2003-12-22
  • Event Date Posted
    2004-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33534
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Reason
    The collar was incorrectly etched for the r (right) and l (left) orientation.
  • Action
    Depuy notified distributors at the various territories via verbal contact on 12/23/2003

Device

Device Recall DePuy Orthopedics
  • Model / Serial
    Lot Number: 226436R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    NY
  • Product Description
    P.F.C. ¿ ¿ Knee System 7¿ || Fluted Femoral Stem 18mmX125mm || REF 96-1703
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA