Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00361-1
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	25/03/2014
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has become aware that there is a remote possibility that the lock washer and screw that secures the monitor onto the SHAPE Arm may not be 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.
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.
Contact Information	1800 803 601 - Stryker Regulatory Affairs & Quality Assurance