Events

Recall of RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform

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
    72598
  • Event Risk Class
    Class 2
  • Event Number
    Z-0391-2016
  • Event Initiated Date
    2015-10-30
  • Event Date Posted
    2015-12-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141630
  • 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
    An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
  • Action
    BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to lpbr5015@biohorizons.com. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.

Device

RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform
  • Model / Serial
    Lot 1404442
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
  • Product Description
    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), || Dental Implant
  • 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