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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01319-1
Product Name/Description Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system

Part Numbers: 352.260S and 351.718.02S

Multiple lot numbers affected

ARTG Number:157016
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/12/2014
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue The expiration date on the label is incorrect. The affected sterile product components (comprising of a locking clip and a drive shaft seal packaged as separate parts) were labelled with expiration dates of 10 years rather than 2 years from the date of manufacturer.
Recall Action Recall
Recall Action Instructions Synthes is advising their customers to check inventory and to quarantine and return any affected units. This action has been closed-out on 07/07/2016.
Contact Information 02 9855 4620 - Synthes Australia. This action has been closed-out on 07/07/2016.