| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00789-1 |
| Product Name/Description |
Comprehensive Nano Humeral Component PPS
Item Numbers:
115730 (Size 30mm)
115732 (Size 32mm)
115734 (Size 34mm)
115736 (Size 36mm)
115738 (Size 38mm)
115740 (Size 40mm)
ARTG Number: 220712 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet is performing a labelling update for the Comprehensive Nano Humeral Component. This product may be used in the anatomic or reverse configuration, however data collected during an annual post market surveillance review, in addition to clinical study data, indicated that the Comprehensive Nano Humeral Component did not meet the Expected Performance Rate (EPR) when used specifically in the reverse configuration.
Due to the Comprehensive Nano Humeral Component exceeding the EPR when used in the reverse configuration, Zimmer Biomet is updating the Instructions for Use (IFU) labelling included with the implant to remove the indication for the reverse configuration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer Biomet is requesting Customers:
1. Review this notification for awareness of the contents;
2. Immediately stop using the affected items in the reverse configuration; usage in the anatomic configuration is permitted in accordance with the current Instructions for Use;
3. There are no specific patient monitoring instructions related to this recall for product correction that are recommended beyond the existing follow up schedule;
4. Complete the supplied Attachment 1 – Certificate of Acknowledgement.
5. Return a digital copy to RAQA.ANZ@zimmerbiomet.com
Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your documentation.
This action has been closed-out on 23/03/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |