Events

Recall of Device Recall Zimmer 4.1 Trabecular Metal" Dental Implant

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
    61481
  • Event Risk Class
    Class 2
  • Event Number
    Z-1510-2012
  • Event Initiated Date
    2012-03-22
  • Event Date Posted
    2012-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108229
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    This zimmer dental voluntary device recall resulted from an investigation into the february 2012 complaint involving an apical tip of a 4.1mm d trabecular metal implant which separated from the implant assembly during surgery on a patient with a dense (type d1), thick, inferior border. the recall correction includes adding precautions to the instructions for use regarding the placement of a 4.1mm.
  • Action
    Zimmer sent an Urgent Medical Device Correction notification letter dated April 24, 2012, with an attached Technical Bulletin listing precautions present in the new Informaiton for Use sent to distributors and customers via E-mail and FED EX. Notifications identified the issue and risks found with the device listing responsibilties, precautions, and procedural precautions. Notifications contained directions to forward information to any sub accounts and clinicians. Zimmer had telephone follow-up with each distributor and customer to assure information was received and is understood. Questions should be directed to Technical Service (800)8511-7019 orCustomer Service(760) 929-1300 or Regulatory Affairs at 1-800-854-7019 . For questions regarding this recall call 574-372-4807.

Device

Device Recall Zimmer 4.1 Trabecular Metal" Dental Implant
  • Model / Serial
    Catalog TMT4B10: Lot 61840378, 61960160, 61967093, 61982587
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Product Description
    Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)
  • Manufacturer
    Zimmer Inc.

Manufacturer

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