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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01019-1
Product Name/Description Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)

Product numbers: 0682001270, 0682001274, 0682000226 & 06824000591

Multiple lot numbers affected

ARTG Number: 118878
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 3/10/2012
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable AC3000 Spring Arm and fallen down together with the monitor until it was only held by the electrical cable connections. An inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. Investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. The frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
Recall Action Recall for Product Correction
Recall Action Instructions Stryker Service Technician to inspect and correct Spring Arm Circlips.
Contact Information 02 9467 1106 - Sofie Parker