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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01191-1
Product Name/Description Shape Arm Kit Left and Shape Arm Kit Right (Mounting/positioning system for flat panel monitors)

Shape Arm Kit Left
Catalogue Number: 0682000976
Serial Numbers: 080924DC001 through 120227DC025

Shape Arm Kit Right
Catalogue Number: 0682000977
Serial Numbers: 080909DB001 through 131021DB013

ARTG Number: 118878
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/12/2015
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue Stryker has become aware that there is a remote likelihood that the lock washer and screw which secure the monitor onto the SHAPE Arm are not present. If the SHAPE Arm lock washer and screw are not present the monitor could separate and dislodge from the Arm potentially resulting in injury. Given the scope of the recall, there is a remote likelihood for this situation to occur.
Recall Action Recall for Product Correction
Recall Action Instructions Stryker is inspecting all affected Shape Arms to determine if the lock washer and screw are missing. If missing a new lock washer and screw will be fitted. This action has been closed-out on 29/08/2016.
Contact Information 1800 803 601 - Stryker Australia