Events

Recall of PyroTitan Humeral Resurfacing Arthroplasty Shapers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LMT Surgical 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-00091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00091-1
  • 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
    It has been determined that certain affected lots of non-conforming product may not be as sharp as intended by design.This may be evident during use by having to increase the applied force to the shaper needed to cut and form the humeral head effectively for the placement of the implant. this increase in force can in-turn, which could create undesirable friction between the shaper and the humeral head that could potentially result in bone tissue being burned.
  • Action
    Integra LifeSciences is advising users that affected stock can be used if there are no alternatives available. Affected stock will be replaced with unaffected units.

Device

PyroTitan Humeral Resurfacing Arthroplasty Shapers
  • Model / Serial
    PyroTitan Humeral Resurfacing Arthroplasty ShapersMultiple Catalogue and Lot Numbers affectedARTG Number: 111050
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd