| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00634-1 |
| Product Name/Description |
Trauma Implants - intramedullary nails
Z NAIL PF 14mm x 46cm UNIV
Item Number: 47-2491-460-14
Z NAIL GT 14mm x 46cm R
Item Number:47-2492-460-14
Z NAIL GT 14mm X 46cm L
Item Number: 47-2492-461-14
All Lot Numbers with an expiry date before May 2027
ARTG Number: 169891 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer is initiating a recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Specifically, multiple test samples from the configuration failed simulated distribution and shipping testing. It is very likely that any damage to the carton box and/or to the outer tray would be detected prior to surgery. The package insert (instructions for use) provided with the device or device system contains a section on sterility. It instructs the user to inspect the package and not use the device if any seal or cavity is damaged. If compromised packaging is detected during surgery, it may result in a slight delay in surgery to obtain another implant. In the unlikely event that compromised packaging is not detected prior to or during surgery by the user, there is a risk of infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to assist their Zimmer Biomet sales representative to quarantine all affected product. There are no specific patient monitoring instructions related to this recall that are recommended beyond the surgeons existing surgical follow up protocol.
This action has been closed out on the 12/09/2018 |
| Contact Information |
02 9483 5426 - Zimmer Biomet |