Events

Recall of Device Recall MTX Dental Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Dental 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
    78667
  • Event Risk Class
    Class 2
  • Event Number
    Z-1190-2018
  • Event Initiated Date
    2017-11-29
  • Event Date Posted
    2018-03-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160090
  • 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
    Two lots of the tapered screw-vent implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
  • Action
    On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.

Device

Device Recall MTX Dental Implant
  • Model / Serial
    Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
  • Product Description
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Manufacturer Address
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA