Events

Recall of Acumed VDR Proximal Targeting Guide

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

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
    16231
  • Event Initiated Date
    2014-02-13
  • 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: Ortho Medics Limited, 586 Great South Road, Ellerslie, Auckland 1051
  • Reason
    There is a chance that the vdr proximal targeting guide will crack and/or break after repeated use in surgery. if a targeting guide breaks during surgery, there is a chance that pieces of the targeting guide may enter the surgery site and cause a delay in surgery and user annoyance.
  • Action
    Product to be returned to supplier

Device

Acumed VDR Proximal Targeting Guide
  • Model / Serial
    Model: Part numbers: 80-0700, 80-0702, 80-0704, 80-0701, 80-0703, 80-0705, Affected: All lots
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    NZMMDSA