| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00660-1 |
| Product Name/Description |
Sterile-Packaged Knee Implants
Part Numbers: 00-5878-065-35, 00-5878-065-41, 00-5886-043-12, 00-5886-043-14, 00-5886-045-12, 00-5886-047-17, 00-5886-048-12, 00-5886-056-10, 00-5886-064-12
Multiple Products and Lot Numbers affected
ARTG Numbers: 227807, 228177, 226498 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been detected with the foil pouches of specific lots of sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. Retrospective testing performed by Zimmer Biomet as a result of an internal review of the packaging system revealed that in some instances, tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample. No product complaints have been reported for this issue. The affected product was distributed between April 2011 and March 2016.
In a worst case scenario, if an issue with the foil pouch is detected during surgery, this will result in a slight delay to obtain another implant. If there is an issue with the foil pouch that goes undetected and also has resulted in a loss of sterility, a peri-prosthetic infection may occur. The risk associated with a peri-prosthetic infection is a revision or potential multi-stage revision to treat the infection. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Peri-prosthetic infections associated with the device/surgical site are most likely to manifest within 12 months of the device being implanted. Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. This action has been closed-out on 27/01/2017. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |