| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01412-1 |
| Product Name/Description |
METS Principal Shaft
Item Number - msfshaft/150
Lot Number - B10562
ARTG Number: 246516 (Stryker Australia Pty Ltd - Femur/tibia shaft prosthesis) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has initiated a lot specific Hazard Alert. The METS product family of components are double pouched in Polyamide/Polyethylene (PA/PE) material and a box. During inspection, certain METS principal shafts were found to be missing the outer pouch. Upon review, two additional principal shafts from the same lot were also discovered to be missing an outer pouch. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Patients implanted with an affected lot number of the METS Principal Shaft should continue to be followed per the normal protocol established by his/her surgeon.
Inform users of this Hazard Alert and forward this notice to all those individuals who need to be aware within your organisation.
Complete the “Hazard Alert Notification Response” form, and return the form to Stryker electronically by email as directed.
This was closed out on the 07/09/2018 |
| Contact Information |
02 9467 1175 - Customer Service Manager |