| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01639-1 |
| Product Name/Description |
Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System
Part Number: 47127
Lot Numbers affected
For screw back-out issue:700942
For oversized condition: 7689802, 7689803, 7766301
ARTG Number: 178654 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
For certain lots of set screw, the manufacturer has become aware of a trend specific to set screw postoperative disengagement from the screw body (set screw back-out). 16 complaints were received from October 2015 through August 2016. In the short term, there is a risk that set screw post-operative disengagement from the screw body at the end of a construct may lead to hardware failure and/or pedicle screw pull-out on adjacent levels, and may also lead to revision surgery. The long term risk is that set screw post-operative disengagement from the screw body may lead to loss of correction, as well as the non-union/non-fusion of bone (pseudoarthrosis).
There is also an unrelated issue for other lots of set screws where a small proportion of lots were manufactured in an oversized condition. For this issue, testing conducted by Alphatec indicates that if the set screw is successfully inserted and locked to the required tightening torque, the construct will perform appropriately. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
For the screw back-out issue, implanting surgeons are being informed to consider more frequent follow-up visits during the initial postoperative phase(s) after surgery. For the oversized condition issue, surgeons are advised that tightening the set screws to the prescribed tightening torque (80in-lbs) should fully mitigate the possibility of an adverse screw body splay event.
This action has been closed out on the 08/11/2018. |
| Contact Information |
02 8887 0100 - Global Orthopaedic Technology Customer Service |