| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01063-1 |
| Product Name/Description |
Scorpio Patella Clamp (used to hold the patella in place during the cementing process)
Item Number: 3182-1000
Tray Item Numbers: 31821000-T, 33023024-T, 80002017-T, 80106661-T, 8200TSX-T
Multiple Lot Numbers affected
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Orthopaedics has received four reports of disassociated components of the Scorpio Patella Clamp. An investigation revealed that the press-fit specifications between the pins and either one or both clamping subcomponents were not met. No adverse patient consequences were reported.
The instrument components, including pins and clamping subcomponents may potentially disassociate and fall into the wound intra-operatively, necessitating retrieval. As such, the potential harms may include:
- Complications associated with extended surgery time
- Inflammatory response
- Tissue damage
- Revision surgery to retrieve loose components |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to inspect stock and quarantine the whole tray immediately if the affected product is found. A Stryker representative will coordinate a replacement clamp or the return of the whole tray that the affected item is in and provide access to unaffected trays as required. This action has been closed-out on 18/05/2017. |
| Contact Information |
02 9467 1175 - Stryker |