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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01023-1
Product Name/Description Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)

Part number: 04.004.XXXSAB

All lot numbers are affected

Supplied under the Special Access Scheme (SAS)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/10/2012
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue Synthes Australia has identified an inconsistency found in the Instructions For Use supplied with the Expert Tibial Nail PROtect. Although no adverse
patient events have been reported due to the identified issue, there is a potential that the use of the Expert Tibial Nail PROtect in indications other
than the ones in the Technique Guide of the Expert Tibial Nail PROtect (036.000.380), may lead to improper application of this device and pose a
health risk for patients.
Recall Action Recall
Recall Action Instructions Customers to return any product held. Sponsor will advise customers once revised Surgical Techniques and Indications for Use are available.
Contact Information 1800 7968437 - Synthes Quality Department