Events

Recall of Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component)

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-2017-RN-01413-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01413-1
  • 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 is recalling the affected batches of the logical 20 degree hooded xlpe liner. the batch numbers are displayed on the product labels. these devices are not intended for the market in australia, and had been distributed following a logistical error.There is no risk to patient safety as a result of this issue.
  • Action
    Signature Orthopaedics is advising users to inspect stock and quarantine any remaining units from the affected batches. There is no additional safety risks or follow up required for implanted devices.

Device

Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabula...
  • Model / Serial
    Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) Catalogue Numbers: 111-12-0250, 111-12-0660, 111-12-0652, 111-12-0656Batch Numbers: 77FAE, 78320, 78347, 7739B, 78334, 7739C-1ARTG Number: 277875 (Signature Orthopaedics Pty Ltd - Logical XLPE Liner - Non-constrained polyethylene acetabular liner)
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd