Events

Recall of DePuy ReClaim Reamer Extension

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

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
    17575
  • Event Initiated Date
    2014-10-23
  • 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
    The manufacturer is recalling specific lots of reclaim® reamer extensions due to the potential for one or both of the tabs to break off and potentially be left in the patient. the reclaim® distal reamer extension has been redesigned, and the company is formally swapping out the affected instruments.
  • Action
    Product to be exchanged

Device

DePuy ReClaim Reamer Extension
  • Model / Serial
    Model: Part Number: 2975-00-500, Affected: Specific lot numbers
  • Manufacturer
    DePuy Ireland UC

Manufacturer

DePuy Ireland UC