Events

Recall of VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)

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-2012-RN-01147-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01147-1
  • 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
    During insertion of viper large diameter long screws in high-torque circumstances (such as placement into the ilium) the screw shank has the potential to separate from the polyaxial head. the disassembly of the screw requires that the shank be removed either via the drive feature in the shank or via alternate methods.
  • Action
    Quarantine and return affected products to Johnson & Johnson Medical.

Device

VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisa...
  • Model / Serial
    VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)Multiple Product Codes All Lot NumbersARTG Numbers: 145290 & 178040
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia