Brainlab Offset Cup Impactor Universal (blue handle) 의 리콜

Recall

RC-2017-RN-00178-1

Class II

2017-02-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00178-1

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.

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.