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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00806-1
Product Name/Description	Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects) Part Numbers: 487.962, 487.963, 487.964, 487.965, 487.974, 487.975 All lots affected ARTG Number: 183673
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/06/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	The fastener on the Mandible Distractor may become prematurely separated from the Proximal Foot Plate. In the event that the Mandible Distractor becomes disengaged from the Proximal Foot Plate during device implantation, surgical delay may occur if another device is not available in the surgical suite. If the Mandible Distractor becomes disengaged from the Proximal Foot Plate after procedure, a repeat surgery may be required to replace the Mandible Distractor/Foot Plates. There may be a risk of local infection as a result of repeat surgery caused by the disengagement since the product is in the oral cavity.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.
Contact Information	02 9815 4646 - Johnson & Johnson Medical