Events

Recall of Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)

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-2015-RN-00302-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-04-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00302-1
  • 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 quality management systems observed an issue with a material used in the packaging of the implants. the packaging component (cap) showed excessive oil which was caused by an issue in production of the raw material (pellets) for manufacturing the caps. nobel biocare's internal analysis has confirmed that this material is not according to the standards. based on the testing performed so far the likelihood that the products cause adverse health consequences is currently considered to be low. the implant batches still at the manufacturing site were restricted for further distribution and placed in quarantine.
  • Action
    Nobel Biocare requested the customer to return the affected product with batch number 13010296. Nobel Biocare is providing a replacement product. This action was underatken prior to notifying TGA.

Device

Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)
  • Model / Serial
    Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)Batch number: 13010296Article number: 37298ARTG Number: 202090
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd