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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01090-1
Product Name/Description	Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System Part number: 03.037.025 Lot Numbers: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407 ARTG Number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/11/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	Upon evaluation, DePuy Synthes discovered that certain lots of the Screw Inserter may potentially be etched with an incorrect graphic. The orientation of the etched image of the oblique angle on the Screw Inserter may be reversed which does not correspond to the tip of the angle of the instrument. This could result in the oblique cut at the lateral end of the screw being at a 90 degree angle to the lateral cortex. It is possible that the user would identify the final lateral oblique angle is not in the desired position, which could result in repositioning the screw within the nail so that the oblique angle of the screw is flush with the bone. The screw is designed to go in either orientation to allow proper depth placement of screw which is a critical factor for the success of the implant.
Recall Action	Recall
Recall Action Instructions	JJM is requesting users inspect all devices in their possession and to quarantine all non-conforming stock prior to their return to JJM. This action has been closed-out on 29/08/2016.
Contact Information	1300 562 711 - JJM Customer Service