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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00185-1
Product Name/Description	Inserter f/TEN Part Number: 359.219 Multiple lot numbers ARTG number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/03/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	The affected lots of the Inserter for Titanium Elastic Nails (TEN) may have the potential for breakage during use. It is important to note that the removal of the TEN Inserter would prevent the performance of emergency surgery, thus Synthes GmbH is not requiring an immediate return of affected product(s).
Recall Action	Recall for Product Correction
Recall Action Instructions	JJM is providing work around instructions to prevent the breaking of the cross/transversal bar and jamming of the chuck. The manufacturer, Synthes GmbH, is in the process of developing the replacement & recovery plan for indicated devices and will contact their customers as replacements become available. This action has been closed-out on 06/06/2016.
Contact Information	1800 252 194 - Johnson & Johnson Medical