Events

Recall of Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier 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-00971-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00971-1
  • 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
    Complaints have been received which describe a non-optimum grip of tibial inserts with the tibial impactor salto talaris which could lead to the fall of the implant. tornier's investigations have led to the conclusion that only sizes 0 and 1 of the tibial implant are not sufficiently maintained by the tibial impactor which, however, remains functional.
  • Action
    Tornier advised their customers that even if the impactor does not ensure optimal holding of sizes 0 and 1 only of the tibial implant, it can still safely be usedand requested that care be taken when using the device for implantation of sizes 0 and 1 of the tibial implants. Tornier is redesigning the device and will notify customers once complete.

Device

Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talar...
  • Model / Serial
    Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)Serial Numbers: 30, 152ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd