Events

Recall of Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic procedures

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-2013-RN-00285-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00285-1
  • 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
    There is an update to the instructions for use (ifu) to reflect that blue free strand orthocord® sutures are expected to retain 80% of their original strength at six weeks after implantation, instead of 100% as indicated in the current ifu.
  • Action
    Updating the Instructions for Use (IFU)

Device

Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet witho...
  • Model / Serial
    Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic proceduresProduct codes: 223111, 223113, 223114, 223115 & 223116ARTG Numbers: 121837 & 121836
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia