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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01018-1
Product Name/Description TomoFix Plate Medial Tibia 4 Hole Standard and TomoFix Small Proximal Medial Tibia 4 Hole 112 mm Titanium Sterile

Part Numbers: 440.834S and 440.831S

ARTG Number: 157069
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/10/2013
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue Following a customer complaint it has been determined that some information in the Surgical Technique Guide and Application Notes on the proximal screw angle and plate thickness is incorrect. A revision has been made to the Surgical Technique Guide and the Application Notes to correct this error.
Recall Action Recall for Product Correction
Recall Action Instructions Synthes is notifying hospitals of the error and is providing updated Surgical Technique Guides for users to follow.
Contact Information 1800 796 843 - Synthes Australia