Events

Recall of Device Recall Endosseous 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
    77911
  • Event Risk Class
    Class 2
  • Event Number
    Z-3210-2017
  • Event Initiated Date
    2017-07-10
  • 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=158318
  • 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
    Zimmer biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard ifus. all the products were missing supplemental ifus.
  • Action
    The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

Device

Device Recall Endosseous Dental Implant
  • Model / Serial
    lot # 63234403, 62358420, 62899483, 63542012, 63220769, 61378631, 62899245, 63409322, 61268685, 62358417, 63091159, 63110269, 63522662, 63529122, 60807237, 62367536, 63471081
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
  • Product Description
    IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; || IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; || IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; || IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; || IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; || IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13
  • 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