| 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 |
|
| 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 |