Events

Recall of DePuy CMW 2 Gentamicin Bone Cement 20 g

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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
    RC-2014-RN-00151-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-02-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00151-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The amount of gentamicin detailed on the unit outer carton label is incorrectly stated as 1.0 m.I.U. (million international units). this should be labelled 0.5 m.I.U. information on the foil pouch and ifu is correct. the composition of the mislabelled bone cement complies with the product specifications and the cement functions according to design intent. the affected lots should be used in the normal manner in accordance with the ifu, and the gentamicin content on the outer carton label for these batches should be disregarded.
  • Action
    Johnson & Johnson Medical are advising users to continue to follow the Instructions for Use (IFU).

Device

DePuy CMW 2 Gentamicin Bone Cement 20 g
  • Model / Serial
    DePuy CMW 2 Gentamicin Bone Cement 20 g Part Number: 3325020 Lot Numbers: 3590475, 3607803, 3620321 and 3625505
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd