Events

Recall of Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system)

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-00977-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00977-1
  • 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
    The surgical technique guides and product labelling for the affected systems currently describe the pedicle awls as 4.0mm for use with screws (4.0mm – 7.0mm). these awls should be used with 5.0mm – 7.0mm screws. in the event that a ø4mm awl is used for a ø4mm screw, there is a risk that perforation of the cortex will be too wide and may result in screw pull-out or loosening. in the event that the cortex is perforated wider than needed for insertion of a ø4mm screw, the failure would not typically be recognised. cases may occur, however, where a surgeon’s perception of torque to insert the screw does not have the desired level of fixation. in this case, the issue may be recognised. there have not been any reports of patient injuries as a result of the current labelling, and there have been no changes to the design or manufacture of the pedicle awls.
  • Action
    Johnson & Johnson Medical are providing a web link for users to obtain copies of the revised technique guides and labelling. This action has been closed-out on 29/08/2016.

Device

Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, ...
  • Model / Serial
    Pangea, USS II Polyaxial, Matrix Deformity, Matrix Degenerative and Pangea Degenerative Systems, Pedicle Awl 4.0mm with Canevasit and Silicone Handle (internal fixation system)Multiple Technique Guides AffectedLabelling:Pedicle Awl 4.0mm with Canevasit HandleProduct Code: 388.550Pedicle Awl 4.0mm with Silicone HandleProduct Code: 388.656ARTG Number: 155807
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes