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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00859-1
Product Name/Description E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)

Reference Number: 3-0499902

Serial Numbers: 159722, 159724, 167258, 169723 and 169979

ARTG Number: 216762
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/07/2017
Responsible Entity Amplitude Australia Pty Ltd
Reason/Issue In December 2016, a recall action was undertaken (RC-2016-RN-01625-1) following customer complaints about the E.TO.I.L.E extension table regarding abnormal wear in the locking system of the external rotation. At this time, the manufacturer, Amplitude were to set up a preventive maintenance on all the E.T.O.I.L.E systems on the market.

An additional analysis of the E.TO.I.L.E extension table has been performed and concludes that a design modification of the locking system is recommended to reduce the risk of lack of locking in external rotation. Therefore, Amplitude has decided to exchange all the E.T.O.I.L.E systems on the market for systems manufactured according to a new design.
Recall Action Recall
Recall Action Instructions As a precautionary measure, Amplitude has decided to exchange all the E.T.O.I.L.E systems on the market by systems manufactured according to new design.

This action has been closed out on 15/01/2019
Contact Information 08 8253 2988 - Customer Service