Events

Recall of SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)

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-2016-RN-01520-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01520-1
  • 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 the potential that the affected lot of the synream flexible shaft may have been manufactured with a non-symmetric hexagonal coupling which may result in the reamer shaft not fitting into the reamer heads. in the event that the flexible shaft cannot be assembled with the reamer head, surgical delay may occur if another device is not available in the surgical suite.
  • Action
    JJM is advising customers to immediately quarantine affected product, and then contact JJM who will arrange for return of the product and replacement. This action has been closed-out on 11/05/2017.

Device

SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary r...
  • Model / Serial
    SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)Part Number: 352.040Lot Number: 9946822The SynReam Flexible Shaft may be contained within the following two kitsLS SynReamKit Number: ZXAUTR1671 Equipment Number: 3000072587 SynReam Kit Number: ZXAUTR2316Equipment Number: 3000108391ARTG Number: 153666
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes