Events

Recall of DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)

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

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-2013-RN-00482-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00482-1
  • 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
    Johnson & johnson medical pty ltd (jjm) has identified the potential for the reclaim reamer extension tabs to break off. 9 complaints worldwide since 2011 have been received reporting tab breakage. none of the complaints have indicated fragments were left in patients.
  • Action
    JJM is advising that users should check the condition of the reamer extension tabs on a regular basis, especially before and after usage. Any reamer extensions showing signs of cracks in the tab area or having broken or missing tabs, should be returned to JJM. Other devices from the affected lots may continue to be used until a design change is implemented and new devices are available.

Device

DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)
  • Model / Serial
    DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)Part Number: 297500500Lot Numbers: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586. NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023 ARTG Number: 191616
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia