Events

Recall of Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile

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-00596-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00596-1
  • 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 manufacturer is recalling dls 3.7mm and 5.0mm following customer complaints of breakages at the distal tip of the pin after successful healing and during planned implant removal of the whole construct. no complaints have been reported by australian customers.
  • Action
    Customers are requested to quarantine all lots of the 3.7 mm and 5.0 mm Dynamic Locking Screws and contact a Depuy Synthes Trauma sales representative to organise the return of the affected devices. Depuy Synthes is also advising implanting surgeons of the appropriate follow up for patients implanted with the potentially affected Dynamic Locking Screw. For further details, please see http://www.tga.gov.au/safety/alerts-device-dynamic-130704.htm

Device

Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Co...
  • Model / Serial
    Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterileDynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm Cobalt-Chrome Alloy (CoCrMo) sterile, Part numbers: 09.213.22S, 09.213.070SDynamic Locking Screw Stardrive 5.0mm, self-tapping, length 32-90 mm, Cobalt Chrome (CoCrMo) sterilePart number: 09.223.032S, 09.223.090SAll lot numbers are affected
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd