Events

Recall of Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Coloplast 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-2017-RN-01542-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01542-1
  • 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
    On november 28, 2017, the therapeutic goods administration (tga) notified coloplast of tga’s decision to remove transvaginal mesh products used to treat pelvic organ prolapse (pop), and single incision mini-slings from the australian register of therapeutic goods (artg), effective january 4, 2018.The tga believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices. further information can be found on the tga website.Following this direction from tga, coloplast is recalling all restorelle directfix anterior, restorelle directfix posterior, and altis single incision sling products from the australian market.No other coloplast devices are affected by this recall.
  • Action
    Coloplast is advising hospitals to quarantine any affected product for return to Coloplast. Instructions for product return are provided on the Customer Letter issued to affected customers.

Device

Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling
  • Model / Serial
    Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision SlingRestorelle DirectFix AnteriorModel/Catalogue Number: 501450SKU Number: 5014501022ARTG 190172Restorelle DirectFix PosteriorModel/Catalogue Number: 501460SKU Number: 5014601022ARTG 190172Altis Single Incision Sling SystemModel/Catalogue Number: 519650SKU Number: 5195601022ARTG 190173
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd