Events

Recall of Tapered HD Upgrade Set, REF TSKHDUS

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
    71125
  • Event Risk Class
    Class 2
  • Event Number
    Z-1605-2015
  • Event Initiated Date
    2015-04-16
  • Event Date Posted
    2015-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136170
  • 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
    Biohorizons tapered hd upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
  • Action
    BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338.

Device

Tapered HD Upgrade Set, REF TSKHDUS
  • Model / Serial
    Lot Number 1501968
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
  • Product Description
    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, || Product Usage Usage: || Surgical instruments used in preparation for dental implant placement
  • Manufacturer
    BioHorizons Implant Systems Inc

Manufacturer

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