Print version of this report
Type of Product
Medical Device
TGA Recall Reference
RC-2016-RN-01616-1
Product Name/Description
Cancellous Bone Screws 16mm, 20mm, 25mm, 30mm, 35mm, 45mm, 50mm
Item Numbers: 203065161, 203065201, 203065251, 203065301, 203065351, 203065451, 203065501
Multiple Lot Numbers
ARTG Number: 242299
Recall Action Level
Hospital
Recall Action Classification
Class III
Recall Action Commencement Date
13/12/2016
Responsible Entity
Stryker Australia Pty Ltd
Reason/Issue
A complaint has been received that on the box label, the country of manufacture ("Made in USA") was incorrectly labelled as “Made in Switzerland” and was missing the CE mark as well as the European Authorised Representative (“EC Rep”) address.
Recall Action
Recall
Recall Action Instructions
Stryker is advising customers with affected stock to return them for replacement or credit.
Contact Information
02 9467 1175 - Stryker