Events

Recall of Device Recall P.F.C.

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
    32192
  • Event Risk Class
    Class 2
  • Event Number
    Z-1181-05
  • Event Initiated Date
    2005-05-26
  • Event Date Posted
    2005-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39654
  • 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
    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.

Device

Device Recall P.F.C.
  • Model / Serial
    Lots Y87G14, Y87G24 and Y87G34.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

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