Events

Recall of NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Straumann 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-00757-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00757-3
  • 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
    A customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
  • Action
    Quarantine and return affected product to the distributors.

Device

NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; arti...
  • Model / Serial
    NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd