Events

Recall of Ascension PyroTitan Humeral Resurfacing Arthroplasty components

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ascension Orthopedics Inc.

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
    15219
  • Event Initiated Date
    2013-08-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: LMT Surgical, 9 Business Connection, 2 Kalmia Street, Ellerslie Greenlane, Auckland 1544
  • Reason
    The manufacturer, ascension orthopaedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
  • Action
    Manufacturer to issue advice regarding use

Device

Ascension PyroTitan Humeral Resurfacing Arthroplasty components

Manufacturer

Ascension Orthopedics Inc