Events

Recall of T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)

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-2014-RN-00852-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00852-1
  • 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’s assessment has identified that incorrect handling of the t-pal applicator instrument could potentially contribute to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-.317 and 03.812.507-517). as a result, the t-pal technique guide (pn 036.001.088) was updated to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0° position. this rigid position is necessary for insertion. if the inner shaft should break in the pivoting position, the assembly cannot be properly advanced into the disc space.
  • Action
    Synthes Australia is requesting their customers to replace the T-PAL Technique Guide with the updated version (PN 036.001.088, Version AD). This action has been closed-out on 03/06/2016.

Device

T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
  • Model / Serial
    T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) ARTG number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd