Events

Recall of Drill set long, drill stop compatible for D 4.8mm

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-2014-RN-01212-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01212-1
  • 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
    Institut straumann has received a customer complaint reporting that 040.447s drill set long, drill stop compatible for d 4.8mm implant lot gy037 contains a green colour coded drill which is incorrectly d3.5mm instead of d4.2mm. the investigation of this complaint has confirmed that the green colour coded drill is only d3.5mm. all other drills within the set 040.477s drill set long, drill stop compatible for d 4.8mm implant are correct. the investigation determined that there are potentially two further drill sets 040.447s that contain an incorrect drill (d3.5mm / green colour coding) and that these drills sets are in one of the listed lot numbers. this issue is limited to article number 040.447s lot numbers gy037, ha443, he874, hl216 only.This action was undertaken prior to the notification to the tga.
  • Action
    Straumann Australia requested the customers to check their inventory and if the article 040.447S Drill set long, drill stop compatible for D 4.8mm Implant Lot HA443 is still in your inventory, please return it to Straumann Australia for credit or replacement. This action was undertaken prior to the notification to the TGA.

Device

Drill set long, drill stop compatible for D 4.8mm
  • Model / Serial
    Drill set long, drill stop compatible for D 4.8mm Implant Article number: 040.447S Lot numbers: GY037, HA443, HE874, HL216
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd