Events

Recall of Depuy P.F.C. E Knee System

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
    44893
  • Event Risk Class
    Class 2
  • Event Number
    Z-0405-2008
  • Event Date Posted
    2007-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64609
  • 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
    Tibial Component - Product Code NJL
  • Reason
    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
  • Action
    Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.

Device

Depuy P.F.C. E Knee System
  • Model / Serial
    Lot 81248A.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    Depuy P.F.C. ¿ E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

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