Events

Recall of Zimmer Dental GemLock RHD2.5 Hex Driver

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
    78321
  • Event Risk Class
    Class 2
  • Event Number
    Z-0279-2018
  • Event Initiated Date
    2017-10-11
  • 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=159177
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Reason
    The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
  • Action
    The recalling firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE RECALL" letters addressed to Clinicians dated 10/11/2017 via FedEx on 10/11/2017. Letters to the distributors dated 10/11/2017 were issued via courier or email on 10/11/2017. The letters described the product, problem and actions to be taken. The customers were instructed to review notification for awareness; review your inventory; immediately return all affected product from your facility to: Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US and complete and return the Certificate of Acknowledgment by fax to 574-372-4265 or email: CorporateQuality.Postmarket@zimmberbiomet.com. If you have further questions or concerns after reviewing this notice, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Zimmer Dental GemLock RHD2.5 Hex Driver
  • Model / Serial
    Lot numbers 63563072, 63572755, 63583270, and 63755802
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
  • Product Description
    Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. || Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
  • 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