Events

Recall of SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays)

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-2013-RN-01102-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01102-1
  • 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
    There is a potential risk of intraoperative reamer head breakages resulting in un-retrieved fragments of non-implant grade material in the surgical site.
  • Action
    Depuy Synthes is advising users to inspect SynReam Sets for the affected lots and return to Synthes for replacement with unaffected stock.

Device

SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam R...
  • Model / Serial
    SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays)Lot Numbers: 20141 to 24510, 15932 to 19396, 24613 to 25347 and 1448284 to 2087630ARTG Number: 153666
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd