Events

Recall of Device Recall Zimmer Metasul Head

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    48715
  • Event Risk Class
    Class 3
  • Event Number
    Z-2299-2008
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71984
  • 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
    hip implant component - Product Code KWA
  • Reason
    The wrong part may be in the package. package may contain a 28 mm head.
  • Action
    Zimmer notified consignees via recall letter dated 6/20/08 to return the product.

Device

Device Recall Zimmer Metasul Head
  • Model / Serial
    Lot 2299218.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Florida, Pennsylvania, Texas and Virginia.
  • Product Description
    Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA