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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