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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01575-1
Product Name/Description	Distraction Screws Packaged sterile (Orthopaedic bone screw) Models: S-0088, S-0089, S-0090 & S-0091 All lot numbers that are still within their labelled 5 shelf life ARTG Number: 263050
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/12/2016
Responsible Entity	CareFusion Australia 316 Pty Ltd
Reason/Issue	Between 1 July 2011 and 30 June 2016, the manufacturer has received 14 reports from customers in the USA of corrosion being evident on screws as they are removed from the immediate packaging. In Australia, no reports of this issue have been received by BD. While no cases have been reported, degradation products of metal corrosion can result in inflammatory response locally and/or systemically. The elderly, pregnant, critically ill and immune-compromised patients may, however, be at greater risk if failure were to occur.
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately quarantine any remaining stock. They will be contacted to arrange return of the quarantined stock. This action has been closed out on the 29/10/2018.
Contact Information	02 8875 7242 - Becton Dickinson