Events

Recall of DePuy S-ROM Noiles Rotating Hinge Femur with Pin

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

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
    17093
  • Event Initiated Date
    2014-09-10
  • 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 company has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the outer carton and shrink wrap are intact.
  • Action
    Product to be exchanged

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin

Manufacturer

DePuy Orthopaedic Technology Inc