Recall of Replace Select Tapered TiU RP 4.6x16mm (fully imbedded dental implant)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nobel Biocare Australia Pty Ltd.

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
    RC-2012-RN-01176-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-11-23
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Nobel biocare australia's quality management systems have detected that some implants from the affected lot number of the replace select tapered tiu rp 4.3x16mm implant may not have been machined correctly, causing the implant driver not to be able to engage the implant. there is no expected risk as the device cannot be implanted if the defect is present.
  • Action
    Quarantine and return affected products for replacement stock.

Device

  • Model / Serial
    Replace Select Tapered TiU RP 4.6x16mm (fully imbedded dental implant)Product Number: 29415Lot Number: 748046ARTG Number: 97386
  • Manufacturer

Manufacturer