Events

Recall of PATH Thread Cup Adaptor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Wright Medical 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-2014-RN-00513-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00513-1
  • 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
    Microport orthopedics inc. have confirmed that some path thread cup adaptors may become difficult to disengage once impacted intra-operatively. path thread cup adaptors are surgical instrumentation used during hip surgery.
  • Action
    Surgical Specialties is requesting their customers to inspect their stock and return any product from the affected lots immediately.

Device

PATH Thread Cup Adaptor
  • Model / Serial
    PATH Thread Cup Adaptor Part Number: 20070013Lot Numbers: 1153896, 1279714, 1288604 & 1314793ARTG Number: 113920
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd