Events

Recall of Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)

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 Synthes.

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-2015-RN-00897-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00897-1
  • 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
    In the affected lots of the application instrument for sternal zipfix :· the end cap may loosen, thus reducing the tension applied to the implant. · the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional.If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
  • Action
    Customers are requested to immediately check their inventory to determine if the facility has any affected product and if so to quarantine those units prior to returning them to JJM for repair. This action has been closed-out on 05/09/2016.

Device

Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum follo...
  • Model / Serial
    Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)Product Number: 03.501.080 Multiple Lot Numbers (see attached)ARTG Number: 153950
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes