Events

Recall of RCI HA ACL Screw

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Signature Orthopaedics 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-2018-RN-00484-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00484-1
  • 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
    Signature orthopaedics has identified that certain batches may be mislabelled, with the packaged component's size not corresponding to the label. therefore, the product intended to be used for the procedure may not be included in the packaging.
  • Action
    Signature Orthopaedics is advising users to quarantine affected stock for return. Replacement stock or a credit note will be issued.

Device

RCI HA ACL Screw
  • Model / Serial
    RCI HA ACL ScrewCatalogue Number: 35130416Batch Numbers: 750ED, 7515DManufacturing Date: 31-7-16Expiry Date: 31-7-21ARTG Number: 193153(Signature Orthopaedics - Prosthesis, internal, ligament, anchor)
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd