| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00934-1 |
| Product Name/Description |
Exeter Non V40 Rasp with plastic handle
(reusable instrument used for the implantation Exeter femoral hip system)
Product Code: 0930-9-003
All lots manufactured between January 1995 and October 2005
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received product complaints stating that a rivet or rivets came off an Exeter Non V40 Rasp Handle. These complaints are associated with the Exeter Rasp Handles with either the green or black plastic lever, manufactured between January 1995 and October 2005. The current Exeter V40 Rasp Handles with a metallic lever are not within the scope of this recall.
In the event that a rivet comes off the Exeter Non V40 Rasp Handle during surgery there are several hazards that would increase surgical time. These include locating the fragment, retrieving a sterilised replacement rasp handle and potentially an intra-operative x-ray if required. The Exeter Non V40 Rasp Handle may continue to function without the rivet. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect inventory and quarantine and remaining units of the affected product for return. This action has been closed out on 15 June 2017. |
| Contact Information |
02 9467 1175 - Stryker |