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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01625-1
Product Name/Description E.T.O.I.L.E sytem extension table (leg holder)
(used in total hip arthroplasty)

Reference: 3-0499902

Serial Numbers: 1500044, E1210021, E1210022, E1210023

ARTG Number: 216762
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/02/2017
Responsible Entity Amplitude Australia Pty Ltd
Reason/Issue Following a customer complaint about the E.TO.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. A failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:
- An increase in the surgery timeline if the incident occurs at the beginning of the surgery.
- A risk of injury for the patient if the incident occurs during surgery.
There have been no reported patient injuries. As a precautionary measure, Amplitude decided to set up a preventive maintenance on all the E.T.O.I.L.E systems on the market.
Recall Action Recall for Product Correction
Recall Action Instructions Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.
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