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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00235-1
Product Name/Description	Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel Part Number: 02.214.108 Lot Number: 9682574 Locking Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel Part Number: 02.214.008 Lot Number: 9674525 (This lot was not distributed in Australia) ARTG Number: 157068
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/03/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	The content of the packaging received may not match the label on the package. The label on the package may indicate a 1.5 mm Cortex Screw with Stardrive recess, self-tapping, length 8 mm, part number 02.214.108 and lot number 9682574. However, the screw in the package may be a 1.5 mm Locking Screw with Stardrive recess, self-tapping, length 8 mm, part number 02.214.008 and lot number 9674525. The difference between these two screws is that the locking screw has a threaded head profile while the cortex screw does not. If the incorrect screw is used, there may be a small surgical delay while a correct screw is located.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical (JJM) is advising users to inspect and quarantine any affected stock and return to JJM. This action has been closed-out on 27/01/2017.
Contact Information	1300 562 711 - Johnson & Johnson