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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01102-1
Product Name/Description SynReam Medullary Reamer Head Ø 8.5 mm (part of the Adolescent Lateral Femoral Nail and SynReam Reaming System Instrument Trays)

Lot Numbers: 20141 to 24510, 15932 to 19396, 24613 to 25347 and 1448284 to 2087630

ARTG Number: 153666
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/10/2013
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue There is a potential risk of intraoperative reamer head breakages resulting in un-retrieved fragments of non-implant grade material in the surgical site.
Recall Action Recall
Recall Action Instructions Depuy Synthes is advising users to inspect SynReam Sets for the affected lots and return to Synthes for replacement with unaffected stock.
Contact Information 1800 796 8437 - Synthes Australia