Events

Recall of Straumann dental surgical drills

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-2016-RN-01543-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01543-1
  • 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
    The investigation of a received complaint has confirmed that the shaft diameter of a drill article number 044.215 lot lv457 is greater than the defined specification of ø2.35mm in the area of the laser marking on the shaft. further investigation has shown that the further articles and lots are also impacted. testing with different handpieces shows that the drills can be inserted. however, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. if the drills do not fit into the handpiece and there is not an alternative instrument available, then the the planned treatment would need to be re-scheduled.
  • Action
    Straumann has advised customers to check their inventory for affected product and return all stock. Straumann will provide replacements. This action has been closed-out on 09/06/2017.

Device

Straumann dental surgical drills
  • Model / Serial
    Straumann dental surgical drillsDrill 1, short, Ø 2.2mm, l 33.0mm, SSArticle #: 044.210 Lot #: MG783Component # Number (on drill): LZ239Twist Drill PRO Ø4.2mm,long,41mm,SSArticle #: 044.255 Lot #: LV455Component Lot # (on drill): LF828 ARTG Number: 119314
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd