Events

Recall of Zimmer Dermacarriers II

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
    47334
  • Event Risk Class
    Class 2
  • Event Number
    Z-1552-2008
  • Event Initiated Date
    2008-04-03
  • Event Date Posted
    2008-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69672
  • 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
    Skin Graft Expander - Product Code FZW
  • Reason
    Sterility compromised. lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
  • Action
    Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products.

Device

Zimmer Dermacarriers II
  • Model / Serial
    All lots.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.
  • Product Description
    Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-015-00. || Single use device for use during skin grafting procedures.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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