Events

Recall of Spectra System/Legacy Guided Surgery Handle Kit Inserts

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Implant Direct Oceania 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-2017-RN-01423-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01423-1
  • 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
    Implant direct oceania pty ltd is informing users of a recall of four (4) lots of spectra system/legacy guided surgery handle kit/inserts due to receiving 3 complaints on these products. through the reporting process, implant direct have found that the g-hk guided surgery handle inserts may be out of implant direct specification. the 3.4mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. in addition, the 2.3mm guide may be too large for the drill. these discrepancies may lead to the possibility of a delay in procedure for the patient if the drilling sequence is discontinued or the clinician would need to continue the surgical procedure without the use of the drill guide. there have been no injuries as a result of this issue.
  • Action
    Implant Direct is advising users to inspect stock and return affected units.

Device

Spectra System/Legacy Guided Surgery Handle Kit Inserts
  • Model / Serial
    Spectra System/Legacy Guided Surgery Handle Kit InsertsPart Numbers: G-HKKit Lot Numbers: 42562, 52987, 64245 and 74772ARTG Number: 296286
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA