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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01367-1
Product Name/Description	MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm (Intended for augmentation or restoration of bony contour in craniofacial defects.) Catalogue Number: 9305 Lot Numbers: A1312011, 77004 & 81799 ARTG Number: 187178
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	16/01/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has become aware that there is a higher occurrence rate of implant damaged during intra-operative handling for the part number noted above. Additionally, a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. Post-operative harm is unlikely to be associated or identified with the use of the affected device.
Recall Action	Recall
Recall Action Instructions	Stryker is informing all the MEDPOR barrier users of the issue and recalling the device. A Stryker Representative will contact the customer to arrange for product return and replacement. This action has been closed-out on 18/07/2016.
Contact Information	1800 803 601 - Stryker Australia