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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01186-1
Product Name/Description 2.7mm Self-Tapping Cortex Screw (internal fixation device)

ASDM Part Numbers: 351-012, 351-014 & 341-016

Lot Numbers: 11164100, 11164200, 11164900 & 11165100

ARTG Number: 134456
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 27/11/2012
Responsible Entity Advanced Surgical Design & Manufacture Limited
Reason/Issue Advanced Surgical Design & Manufacture Ltd, following a report of a fracture of the screw head during surgery, has determined that the affected products may be out of specification.
Recall Action Recall
Recall Action Instructions Advanced Surgical Design and Manufacture is asking customers to quarantine and return all affected devices for replacement stock.
Contact Information 02 9439 4448 - Advanced Surgical Design and Manufacture Regulatory Affairs