Events

Recall of Synthes SynFix-LR Implant Holder

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

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
    16641
  • Event Initiated Date
    2014-05-06
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Reason
    Complaints have been received which describe the synfix-lr implant holder breaking at the interface between the implant and holder. if an un-retrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix-lr aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix-lr screws into the synfix-lr implant (plate) and vertebral bodies. if the tip of the holder should break, the potential exists for an un-retrieved device fragment (urdf) to be left in the synfix-lr implant.
  • Action
    Instructions for use to be updated

Device

Synthes SynFix-LR Implant Holder
  • Model / Serial
    Model: Part Number 03.802.039, Affected: All lots
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH