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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-01059-1
Product Name/Description AMPLITUDE Orthopaedic Surgical Instruments

ARTG Number: 178179
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/10/2014
Responsible Entity Amplitude Australia Pty Ltd
Reason/Issue AMPLITUDE identified an error regarding the automated cleaning process in the Instructions For Use (ref. NO103 indices J, K and L) supplied with its surgical instruments since 2012. The protocol is not the correct one and does not correspond to the validated cycle, although it is applicable for the universal handle (REF. 2-0232100). The automated cleaning (washer - disinfector step) in the IFU incorrectly states to process in a solution of alkaline detergent (e.g. 5% MEDICLEAN) for 15 minutes at 40°C. The correct procedure is to process in a solution of alkaline detergent (e.g. 0.5% MEDICLEAN) for 10 minutes at 93°C.
Recall Action Recall for Product Correction
Recall Action Instructions A copy of the revised Instructions For Use NO103 – revision M is attached with the customer letter. Amplitude is asking the customers to verify the automated cleaning parameters in the revised instructions for all other Amplitude instruments (except the universal handle). This action has been closed-out on 18/03/2016.
Contact Information 08 8297 9901 - Amplitude Australia Pty Ltd