Events

Recall of Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew 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-2016-RN-01035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01035-1
  • 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
    Several batches of whipknot soft tissue cinch #5 sutures have a potential packaging issue. a smith & nephew internal evaluation revealed that the packaging design is insufficient to prevent a potential sterile barrier breach (pin hole) in the tyvek film of the pouch.If the sterile barrier breach is not detected prior to use, the compromised packaging could potentially lead to a non-sterile device entering the surgical field.To date, there have been no complaints or adverse events associated with this issue.
  • Action
    Smith & Nephew is advising users to immediately locate and quarantine affected devices. Affected stock will be replaced with unaffected product.

Device

Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placeme...
  • Model / Serial
    Whipknot Soft Tissue Cinch #5 Sutures (used in assisting in the harvest, preparation, and placement of soft tissue grafts during ligament reconstructive surgery)Product number: 7211015Multiple batch numbers affectedARTG number: 99843
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd