Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-01356-1 |
Product Name/Description |
Trident Tritanium Acetabular Window Trials Case
Catalogue Number: 24024020
Lot Number: 032173
ARTG Number: 140892 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
23/12/2013 |
Responsible Entity |
|
Reason/Issue |
Stryker has become aware that some outer trays of the Trident Tritanium Acetabular Window Trials Case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. The hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. Note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray. |
Recall Action |
Recall |
Recall Action Instructions |
Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product. |
Contact Information |
1800 803 601 - Stryker Australia |