Events

Recall of SynFix-LR Surgical Implant Holder

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-2014-RN-00445-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00445-1
  • 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
    Complaints have been received which describe the synfix lr implant holder breaking at the interface between the implant and holder breaking at the interface between the implant and holder. if an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix screws into the synfix implant (plate) and vertebral bodies. if the tip of the implant holder should break, the potential exists for an unretrieved device fragment (urdf) to be left in the synfix-lr implant.
  • Action
    DePuy Synthes is updating the SynFix-LR Surgical Technique Guide and notifying their customers that the SynFix Set Case design has been updated to incorporate two additional wrenches to facilitate correct assembly/disassembly and an additional implant holder to facilitate continuation of surgery. Customers are also reminded that an alternative instrument to the implant holder (SQUID, 03.802.121) can be used for the insertion of the implant in suitable cases.

Device

SynFix-LR Surgical Implant Holder
  • Model / Serial
    SynFix-LR Surgical Implant HolderPart Number: 036.000.915ARTG Number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd