| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01402-1 |
| Product Name/Description |
TunneLoc Tibial Fixation Devices (used during anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction)
All lot Numbers affected
Item Numbers: 906512, 906513, 906514, 906515
ARTG Number: 208040 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet is conducting a Hazard Alert for the TunneLoc Tibial Fixation devices due to gamma sterilisation validation testing associated with external pack vendors that indicates the sterilisation dose may not be adequate. This may result in an increased likelihood of infection following implantation. There have been no reports of injuries associated with this issue. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer is advising customers to continue the existing patient follow up schedule. There are no additional requirements for patients.
This action has been closed out on the 08/11/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet Sales Associate |