Events

Recall of EXTERNAL DENTAL IMPLANT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOHORIZONS CANADA SUBS. OF 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
    24179
  • Event Risk Class
    III
  • Event Initiated Date
    2007-04-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

Device

EXTERNAL DENTAL IMPLANT SYSTEM
  • Model / Serial
    Model Catalog: 134-350 (Lot serial: 08060239); Model Catalog: 300-351 (Lot serial: 06060009); Model Catalog: 320-000 (Lot serial: 06060009); Model Catalog: 300-337 (Lot serial: 06060009); Model Catalog: 300-350 (Lot serial: 08060239); Model Catalog: 300-337 (Lot serial: 08060239); Model Catalog: 320-000 (Lot serial: 08060239); Model Catalog: 300-351 (Lot serial: 08060239); Model Catalog: 300-350 (Lot serial: 06060009); Model Catalog: 134-350 (Lot serial: 06060009); Model Catalog: 300-351 (Lot serial: 09040003); Model Catalog: 320-000 (Lot serial: 09040003); Model Catalog: 300-337 (Lot serial: 09040003); Model Catalog: 300-350 (Lot serial: 09040003); Model Catalog: 134-350 (Lot serial: 09040003); Model Catalog: 300-351 (Lot serial: 11060189); Model Catalog: 320-000 (Lot serial: 11060189); Model Catalog: 300-337 (Lot serial: 11060189); Model Catalog: 300-350 (Lot serial: 11060189); Model Catalog: 134-350 (Lot serial: 11060189)
  • Product Description
    EXTERNAL DENTAL IMPLANT SYSTEM
  • Manufacturer
    BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS INC.

Manufacturer

BIOHORIZONS CANADA SUBS. OF BIOHORIZONS IMPLANT SYSTEMS INC.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Henry Schein Inc
  • Source
    HC