Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00389-1
Product Name/Description	PANTA Arthrodesis Nail & PANTA XL Arthrodesis Nail (Intramedullary tibial nail) Catalogue number: 500-050, 500-080, 500-150, 500-180, 500-250, 500-280, 500-350, 500-380, 510-111, 510-141, 510-211, 510-241, 510-311, 510-341 All batch numbers are affected. ARTG Number: 173962
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/04/2013
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	Incidents reported to the manufacturer, Newdeal SAS France, were attributed to the misalignment of the calcaneal or tibial screws and the PANTA Arthrodesis Nail, with or without clinical consequence during PANTA Arthrodesis Nail surgery. Therefore, additional surgical precautions are being added to the Surgical Technique.
Recall Action	Recall for Product Correction
Recall Action Instructions	The manufacturer through Integra is revising the surgical technique to include additional precautions.
Contact Information	1300 550 599 - Integra Customer Service