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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00948-1
Product Name/Description Cortex Screw Ø 3.5 mm, self-tapping, length 28 mm, Stainless Steel

Part Number: 204.828

Lot Numbers: 8573875; 8594066

ARTG Number: 157068
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/08/2014
Responsible Entity Synthes Australia Pty Ltd
Reason/Issue Due to a manufacturing error, a Cortex Screw Ø 3.5 mm, self-tapping, length 30 mm, Stainless Steel (part number 204.828) with an unfinished thread and malformed tip was packaged and labeled as a Cortex Screw Ø 3.5 mm, length 28 mm, Stainless Steel (part number 204.028).

If the presence of a screw that is 30mm instead of 28mm, with a tip that is malformed, is detected, a marginal surgical delay may arise as an alternative screw is selected. The potential for a delay increases if multiple screws of the incorrect length/malformation are present in the graphic case. If the presence is not detected, the surgeon may attempt to utilize the screw during a surgical procedure. When the surgeon attempts to insert the screw, the diameter of the non-threaded ball-like tip of the screw will not fit into the hole that is drilled. Therefore insertion will not be possible.
Recall Action Recall
Recall Action Instructions Customers are asked to check their inventory immediately for the affected units and if they have any of the affected devices to immediately isolate them. This action has been closed-out on 03/02/2017.
Contact Information 1800 796 8437 - Synthes Australia Pty Ltd