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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00338-1
Product Name/Description Flexible Handle for Simplified Universal Nail System (SUN) and the Universal Nail System (UNI) (Re-usable surgical instrument supplied as part of internal fixation system implantation kit)

Flexible Handle Part Number: 355.280
ARTG Number: 153950
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/04/2013
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue The manufacturer has identified that there is a potential lack of the ability to thoroughly clean the instrument.
Recall Action Recall
Recall Action Instructions The affected handle is being recalled and replaced with a new design of handle.
Contact Information 02 9855 4620 - Synthes Australia