| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00150-1 |
| Product Name/Description |
HV Sterile Screws
Multiple products
ARTG 198485
(Stryker Australia Pty Ltd - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has identified a potential nonconformance within four specific lots of the HV screws. The screws may be missing the cannulation. This nonconformance prevents the screws from being able to be inserted over the k-wire intraoperatively. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to:
1. Check stock and dispose of any affected product.
2. Return the customer acknowledgment letter to Stryker with the details of all affected product that has been disposed of.
3. If they have loaned, sold or disposed of any affected product, to inform Stryker immediately.
A Stryker representative will coordinate the replacement of any affected product. |
| Contact Information |
0439 661 638 - Samantha Holland, Post Market Associate |