Events

Recall of Application Instrument for Sternal ZipFix

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes Australia 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-2013-RN-00924-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00924-1
  • 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
    There is potential for zipfix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. the possibility exists for the zipfix implant to be compromised and loosen after implantation or during the post operative recovery period.
  • Action
    Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.

Device

Application Instrument for Sternal ZipFix
  • Model / Serial
    Application Instrument for Sternal ZipFixPart Number: 03.501.080Lot Number: All 1st generation Application Instruments - Lots prior to 8100630ARTG Number: 153950
  • Product Classification
    Orthopedic Devices
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd