Events

Recall of Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Lima Orthopaedics 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-2017-RN-01331-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01331-1
  • 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
    A lima orthopaedics investigation detected substandard welding performed by the supplier on the beater-positioner-aligner. specifically, the absence of base material pre-fusion and under-dimensioned welding radius was identified. there is a risk of injury to the surgeon or the patient, in case the flange of the instrument breaks and detaches with high speed from the body of the instrument.
  • Action
    Lima is advising users to quarantine affected stock from use. Lima Orthopaedics will replacing the affected stock in the consignment sets.

Device

Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)
  • Model / Serial
    Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)Product Code: 9057.20.555Lot Numbers: 15AG0V0 and 16AG02JARTG Number: 176877
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd