| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01246-1 |
| Product Name/Description |
Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)
Catalogue Number: 62789970
Lot Number: 039980
ARTG Number: 140892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware that the trays of the affected lot number are missing two of the four necessary cut outs. These cut outs provide clearance to secure the clips on the tray lid to the base. The hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips, making the contents of the tray unsterile. A potential tear would likely be noticed by the surgical staff before the instrument is used as the blue wrap is checked for any defects prior to surgery. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising users to remove any affected trays from use. Any affected trays will the replaced by Stryker. |
| Contact Information |
1800 803 601 - Stryker Australia Quality Assurance |