Events

Recall of Nobel Biocare Replace Select TiU RP 4.3 x 16 mm Implant

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

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
    13824
  • Event Initiated Date
    2012-11-22
  • 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: Nobel Biocare New Zealand Ltd, Ground Floor, 110 Symonds Street, Auckland 1150
  • Reason
    Quality maagement systems detected that some implants from specific lot may not have been machined correctly, causing the implant driver not to be able to engage the implant. this could cause inconvenience but does not affect the patient safety.
  • Action
    Product to be returned to supplier

Device

Nobel Biocare Replace Select TiU RP 4.3 x 16 mm Implant
  • Model / Serial
    Model: Product Number: 29415, Affected: Lot: 748046
  • Manufacturer
    Nobel Biocare AB

Manufacturer

Nobel Biocare AB