| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00069-1 |
| Product Name/Description |
Mizuho OSI 5855 Orthopedic Table Top
Manufactured January 1996 through December 2007
ARTG 183118 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
This action has been initiated to eliminate the risk of de-lamination of the epoxy bond between the 5855-01 Orthopedic Table Spar's aluminium insert and the carbon fibre spar itself. If the epoxy bond fails the aluminium plug may migrate out of the carbon fibre tube. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are being advised to inspect the table top for any evidence of a shift of the aluminium plug from the carbon spar and immediately contact LifeHealthcare if apparent. Hospitals will be contacted to schedule an appointment to replace the table spar. |
| Contact Information |
02 8114 1551 - Life Healthcare Regulatory Affairs |