Events

Recall of Device Recall Zimmer dental

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
    55889
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-2011
  • Event Initiated Date
    2010-05-18
  • Event Date Posted
    2010-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92220
  • 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
    dental implant instrument - Product Code OFY
  • Reason
    The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
  • Action
    Zimmer sent out "Urgent Device Correction" letters dated 5/18/2010. The consignees were provided with new instructions for use. The letter informed users that the current pre-vacuum cycle of 3 to 18 minutes is not enough time to assure sterility between the lid-kit interface and could lead to cross contamination of multiple patients. The users were informed that a pre-vacuum time of 30 minutes was required to assure sterility.

Device

Device Recall Zimmer dental
  • Model / Serial
    61482528, 61484443, 61495269 and 61479592.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution Nationwide, to France, and Spain.
  • Product Description
    Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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