Events

Recall of Synthes PFNA End Cap Extension 0 T40 tan

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
    19637
  • Event Initiated Date
    2015-12-24
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Reason
    Part and lot number of the pfna end cap may have the incorrect anodized colour., an implant wth the incorrect anodized colour would not cause harm to the patient- a sugical delay may resut if surgeon noticed the nonconforming colored nail and selected a nail of the correct color, length, design and diameter.
  • Action
    Product to be returned to supplier

Device

Synthes PFNA End Cap Extension 0 T40 tan
  • Model / Serial
    Model: 04.027.000S, Affected: Lot No: 2681953
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH