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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