| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00178-1 |
| Product Name/Description |
Brainlab Offset Cup Impactor Universal (blue handle)
Catalogue Numbers: 52856, 52856A
ARTG Number: 121094 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been detected that when the Brainlab Offset Cup Impactor Universal (blue handle) is reprocessed in a Sterilisation Tray as described in the current Brainlab Cleaning, Disinfection and Sterilisation Guide (Revision 5.2 and previous versions), the device may not be determined as sterile. The required sterility assurance level (SAL) of 10-6 can only be achieved if the device is individually wrapped for sterilisation. If a non-sterile Brainlab Offset Cup Impactor Universal (blue handle) is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to an infection. At this stage, there have been no reports of affected patients due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Brainlab is advising users to follow the sterilisation instructions in the current version (BL-IL-60960-69ML Rev. 1) of the IFU. Users are reminded that in addition to following the other instructions in the IFU, the Offset Cup Impactor Universal (blue handle) must be sterilized in an individually wrapped configuration.
This action has been closed out on the 09/10/2018. |
| Contact Information |
02 9424 3800 - Brainlab Australia |