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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00591-1
Product Name/Description	Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium (Craniofacial fixation plate) Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium Part Number: 421.021 Multiple lot numbers affected Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium, sterile Part Number: 421.021S Multiple lot numbers affected ARTG Number: 157706
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	30/05/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The affected part and lots numbers of the "Orbital Rim Plate" have been mislabelled as "Orbital Floor Plate". The mislabelling non-conformance may result in user dissatisfaction, but is not likely to impact the patient.
Recall Action	Recall for Product Correction
Recall Action Instructions	DePuy Synthes is notifying their customers of the correct label information for the Orbital Rim Plate and Orbital Floor Plate.
Contact Information	1800 796 843 - Synthes Australia Toll Free