| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01192-1 |
| Product Name/Description |
Arthrex ITD Articulating Arm 300 + 350MM
Product Code: AR-5995SAS-FP30
Serial Numbers: 001-061736, 001-061740, 001-061742, 001-061745
ARTG Number: 207096 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that the rivets of the rotation on the item ‘VESA 75 / 100 adapter connection with rotation’, which is an integral part of the Articulating Arm 300 + 350mm, may not have been executed in accordance with the relevant standards. The rivets may be weak. In exceptional cases, the connection panel may become loose or detached when subjected to continuous operation. This may potentially endanger the safety of patients, users or third parties. There have been no reported cases of loss or damage in the field related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that a repair kit will be provided to all affected customers to correct the device. This action has been closed-out on 18/05/2017. |
| Contact Information |
03 9371 0900 - Device Technologies |