Events

Recall of Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)

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-01053-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01053-1
  • 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, limacorporate has received two complaints about the allen wrench. firstly, the impossibility to connect the allen wrench to the t-handle intra-operatively. secondly, after a difficult insertion, it was impossible to remove the allen wrench from the t-handle. in both cases, there were no reported consequences for the patients. limacorporate's investigations have shown that the diameter of the zimmer connection on the allen wrench has been manufactured out of specification and is over-dimensioned. this leads to difficult/impossible coupling between the allen wrench and the t-handles.
  • Action
    Lima Orthopaedics' kit coordinator will be visiting hospitals and replacing affected devices in the SMR instrument sets with unaffected devices. This action has been closed-out on 20/02/2017.

Device

Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation ...
  • Model / Serial
    Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)Allen Wrench 5mmProduct Code: 9013.50.210Lot Number: 14AA311 SMR instrument setProduct Codes: 9013.23.000, 9013.43.000, 9013.45.000ARTG Number: 176592
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd