Events

Recall of Synream Medullary Reamer Head Size 13.5mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-2015-RN-01241-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01241-1
  • 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 affected part number and lot number is etched as dimension 13.5mm while the actual dimension is 14mm.If a 14mm reamer head is labelled and etched as a 13.5mm, there is the potential that the surgeon would be advancing 1.0mm versus 0.5mm; thus, there is a risk of the reamer head jamming. surgical delay could occur as the reamer head is removed from the medullary canal and bone debris is removed or the reamer head is replaced with another reamer head. there is also the potential for damage to the bone.
  • Action
    JJM is advising users to inspect stock and return any of the affected product to JJM for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Synream Medullary Reamer Head Size 13.5mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes