Events

Recall of Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioHorizons Implant Systems 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
    67090
  • Event Risk Class
    Class 2
  • Event Number
    Z-1058-2014
  • Event Initiated Date
    2013-12-10
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124682
  • 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
    The body length of the external implant 40105d3 lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
  • Action
    The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to implants@biohorizons.com; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In addition, if you have already placed any affected implants without incident, no special patient action needs to be taken. If you have any questions regarding this information, please contact our Customer Care Department at (888) 246-8338, Monday through Friday, 7:30am to 6:00pm Central Time.

Device

Device Recall External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3
  • Model / Serial
    Lot Number 1302762, Exp 31 MAY 2018
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
  • Product Description
    External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 || Usage: dental
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

BioHorizons Implant Systems Inc
  • Manufacturer Address
    BioHorizons Implant Systems Inc, 2300 Riverchase Center, Birmingham AL 35244-2808
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    USFDA