| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00984-1 |
| Product Name/Description |
Vanguard Open Box Posterior Stabilised Femoral Components
Item Number :183106
Lot Number: J3842173
Item Number: 183106
Lot Number: J3844489
ARTG Number: 218510 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified an issue with Vanguard Open Box Posterior Stabilised Femoral Components where inadequate line clearance at the supplier between 5 April 2016 and 1 September 2016. As a result, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). It is highly detectable at the point of use that the device was incorrectly labelled. The estimated rate of occurrence is <1 in 1,000 products. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer is requesting surgeons:
1. Review the notification and ensure affected personnel are aware of the contents;
2. Complete the Certificate of Acknowledgement supplied with the customer letter, then
a. Return a copy to RAQA.ANZ@zimmerbiomet.com; and
b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.
3. If after reviewing this notice there are further questions or concerns please contact the local Zimmer Biomet representative.
This recall was finalised on 14/09/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |