Events

Recall of Device Recall Zimmer Dental AdVent Implant System, Abutment, Tapered

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
    53813
  • Event Risk Class
    Class 2
  • Event Number
    Z-0499-2010
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2009-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86570
  • 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
    Endosseous dental implant - Product Code DZE
  • Reason
    The devices may not meet specifications, which may result in fracturing during tightening of the component.
  • Action
    User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.

Device

Device Recall Zimmer Dental AdVent Implant System, Abutment, Tapered
  • Model / Serial
    Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Ohio, Canada and France.
  • Product Description
    Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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