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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00646-1
Product Name/Description	Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm (non-biodegradeable orthopaedic bone screw) Part Number: 400.808 Lot Number: 2798707 ARTG Number: 157068
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/06/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The packaging for item 400.688S (Cortex Screw Ø 1.3 mm, self-tapping, length 8 mm, sterile) was found to contain product 400.808S (Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm, sterile). The presence of a screw that is 1.5mm in diameter instead of 1.3mm (or 1.3mm vs 1.5mm) may cause surgical delay if the surgeon may specifically require a 1.3 or 1.5mm due to the patient's impacted anatomical structure.
Recall Action	Recall
Recall Action Instructions	Customers are requested to isolate Cortex Screw Ø 1.5 mm, self-tapping, length 8 mm from the affected lot for return to DePuy Synthes.
Contact Information	02 9855 4620 - Synthes Australia