Events

Recall of SMR Glenosphere Impactor

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-2016-RN-00578-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00578-1
  • 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
    Lima orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors.The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient.
  • Action
    Customers are advised to inspect stocks and quarantine the affected units prior to their return. This action has been closed out on 20/01/2017.

Device

SMR Glenosphere Impactor
  • Model / Serial
    SMR Glenosphere ImpactorProduct Code: 9013.74.141Lot Numbers: 1390763, 14AA094, 14AA528, 15AA557ARTG Number: 176877
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd