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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00624-1
Product Name/Description Transpedicular Schanz Screw (Bone screw for internal spinal fixation system)

Part Number: 496.711, 496.712, 496.715, 496.721, 496.722, 496.723, 496.724, 496.725, 496.780

Multiple lot numbers affected

ARTG Number: 133401
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/06/2013
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue Complaints have been received that advise that the fracture clamp could not be used with the affected screws because the end of the screws were manufactured out of specification (too thick).
Recall Action Recall
Recall Action Instructions Hospitals are being requested to inspect inventory, isolate stock and return the affected stock to Synthes Australia.
Contact Information 1800 796 843 - Synthes Australia