Events

Recall of BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kerr 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-2012-RN-01124-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01124-1
  • 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
    It has come to the attention of kerr australia that disturbing the bioplant product soon after it is placed may halt or delay the ossification process.
  • Action
    Update to Instructions for Use (IFU).

Device

BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)
  • Model / Serial
    BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)BioPlant Curved Syringe 0.125gPart Number: 216110BioPlant Curved Syringe 0.25gPart Number: 216112BioPlant Curved Syringe 0.50gPart Number: 216114BioPlant Curved Syringe 0.25g (2 pack)Part Number; 216132BioPlant Intro PackPart Number: 216112B(Synthetic dental bone grafts)All production lots within shelf lifeARTG Number: 121686
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd