| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00530-1 |
| Product Name/Description |
MIA16 Minimally Invasive Attachment used with the Anspach
Product Insert version 18-0074 Rev A 05/12
ARTG Number: 141597 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
During hydrogen peroxide sterilisation testing of the MIA16 device it was determined that the Sterrad 100S is not capable of achieving the expected sterility assurance level (SAL) of 10^-6. Therefore, Sterrad 100S should not be used for sterilising the MIA16 attachment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to not use the Sterrad 100S to sterilise the MIA16 attachment. |
| Contact Information |
1800 796 843 - Synthes Customer Service |