| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01137-1 |
| Product Name/Description |
Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)
Item Number: 2101-0200
Multiple Lot Numbers affected
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant. Upon investigation, it was determined that the press fit between the threaded stud and the handle shaft assembly for the Trident Universal Impactor/Positioner may lead to the gradual protrusion of the threaded stud over time. This may result in a delay in surgery, fracture or pain associated with the implant loosening. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect inventory and quarantine affected product for return. This action has been closed out on 16 June 2017. |
| Contact Information |
02 9467 1175 - Stryker (Recall Specialist) |