Events

Recall of Holding Forceps for SynReam Reaming Rod 2.5 mm (used during surgery to retain an instrument, reduce a fracture, spread an osteotomy, or hold an implant in place)

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-00097-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-01-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00097-1
  • 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 angle of the locking lever of holding forceps from the affected lots has the incorrect angle and may not lock, resulting in the forceps inability to retain the desired position once applied.
  • Action
    Synthes is advising users to inspect stock and quarantine any affected products to return to Synthes.

Device

Holding Forceps for SynReam Reaming Rod 2.5 mm (used during surgery to retain an instrument, redu...
  • Model / Serial
    Holding Forceps for SynReam Reaming Rod 2.5 mm (used during surgery to retain an instrument, reduce a fracture, spread an osteotomy, or hold an implant in place)Lot Numbers: 5923464 and 5923181ARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd