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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00980-1
Product Name/Description	Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System) Model Number: 71642365 Batch Numbers: 12BM01456, 12FM15060, 12JM09146, 13AM18101, 13EM08756, 13GM11807, 13GM11808, 13GM18304, 13GM20483, 13GM20486, 13HM20836, 15CM19083, 15FM02129 ARTG Number: 104369
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/07/2016
Responsible Entity	Smith & Nephew Pty Ltd
Reason/Issue	Smith & Nephew Pty Ltd is advising several lots of Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm were supplied with incorrect Instructions for Use (IFU). The Fracture Fixation IFU (Reference 81078017) was packaged with the device instead of the correct Intramedullary Nail System IFU (Reference 81090283). Affected products do not need to be returned. The affected products meet all other product specifications and can be used.
Recall Action	Recall for Product Correction
Recall Action Instructions	Smith & Nephew are providing users with the correct Instructions for Use (IFU). This action has been closed-out on 23/05/2017.
Contact Information	02 9857 3908 – Smith & Nephew