| 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 |
|
| 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.
This action has been superseded by RC-2017-RN-00859-1 |
| Contact Information |
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