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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00439-1
Product Name/Description SerenoCem Granules BCG050 (Orthopaedic bone cement)

All lots affected

ARTG Number: 152441
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/07/2016
Responsible Entity Endotherapeutics Pty Ltd
Reason/Issue The manufacturer, Corinthian Surgical Ltd has been made aware of a cluster of cases in the United Kingdom where it has been observed that there has been some bone re- absorption in the area adjacent to the granules in the middle ear. This can lead to exposure of the dura and facial nerve, potentially resulting in infection and/or brain herniation.

As a precautionary measure Corinthian Surgical Ltd is temporally suspending the supply of SerenoCem Granules and there should be no further use of the granules at this time. The cause of the reported cases of bone resorption is currently under investigation.
Recall Action Hazard Alert
Recall Action Instructions Endotherapeutics is recommending that if a patient presents for a routine checkup or at the 2 yearly follow up, to perform a CT scan. Outside of these circumstances, patients should undergo a CT scan at the clinical discretion of the treating surgeon. Any remaining unused stock should be quarantined and returned to Endotherapeutics. The investigation is currently ongoing, and further communications may be required following completion of the investigation and in consultation with the Therapeutic Goods Administration (TGA).

This action has been closed out on the 29/10/2018.
Contact Information 02 9869 2868 - Endotherapeutics