| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01262-1 |
| Product Name/Description |
VariAx 2 3.5 mm screws
Catalogue Numbers: 657308 – 657332 and 657408 – 657432
Multiple Lot Numbers affected
Included in VariAx Compression EPS system tray
Catalogue Number: 940081-T
All lot numbers affected
ARTG Number: 239272 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
During a product presentation it has been recognised that a screw is not held by the screwdriver blade. The missing retaining function is caused by the inner torx of the screws partly being out of specification. Investigations have revealed that screws might exceed given tolerances.
A missing retaining function can lead to the surgeon having difficulties to pick the screw out of the screw rack without any further means, such as tissue forceps or other forceps, or during transfer of the screws. Difficulties during pick up or transfer of the screws could potentially cause additional time under anaesthesia due to prolongation of surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is advising users that the affected screws can be continued to be used and will be replaced once unaffected stock is available. This action ha been closed-out on 29/08/2016. |
| Contact Information |
02 9467 1289 - Stryker |