Events

Recall of Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short Attachments

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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-2014-RN-00040-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00040-1
  • 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
    Laser marking location is out of specification (i.E., greater than 2.00 inches from the distal end of the cutting burr). fracture of the carbide cutting bur could occur if short cutting burrs with an out of specification laser location were used with an attachment that may have worn bearings. cutter fracture could result in user laceration, re-operation due to remaining fragments, soft tissue damage due to fragment retrieval, and delay in surgery.
  • Action
    Synthes is advising users to return affected units.

Device

Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with ...
  • Model / Serial
    Anspach Short Carbide Cranial Cutting Burrs - 1.5 mm x 7.5 mm Cylindrical Carbide Drum used with Short AttachmentsPart Number: S-15DRMCMultiple lot numbers affectedARTG Number: 141597
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd