| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01092-1 |
| Product Name/Description |
Trinica Ratchet Handles (included in the Anterior Lumbar Plate (ALP) Instrument Tray)
Part Number: 07.00438.001
Instrument Tray Part Number: 07.01058.001
ARTG Number: 179397 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The ratchet handles may not be effectively sterilised if left in their designated locations in the instrument tray. This is due to the current bracketing in the tray potentially interfering with complete steam penetration into the cannulated handle. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is advising users to sterilise the Ratchet Handles externally to the instrument tray. Replacement trays are currently being designed and will be available by July 2014. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |