Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00651-1
Product Name/Description Anspach Attachments and Handpieces (reusable surgical devices)

Multiple part numbers and lot numbers

ARTG Numbers: 141597, 141559, 141600, 146267 and 155913
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/06/2014
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue Internal testing of STERRAD® 100S sterilisation process has shown that several Anspach attachments and handpieces did not achieve the expected sterility assurance level (SAL) of 10-6.
Recall Action Recall for Product Correction
Recall Action Instructions Synthes Australia is notifying their customers of the removal of the recommendation to sterilise Anspach Attachments and Handpieces in the STERRAD 100S (Hydrogen Peroxide Gas Plasma Technology). Steam sterilisation method is still validated for the sterilisation of these devices.
Contact Information 02 9855 4620 - Synthes Australia