| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00819-1 |
| Product Name/Description |
Trauma Guide Wires, 70cm
Ball Tip Guide Wire 2.4mm
Item Number: 47-2255-008-00
3mm x 70cm Tear Drop Guide Wire
Item Number: 47-2490-098-00
Expiry Date: April 2022
ARTG Number: 118540 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The design verification for the previous packaging configuration does not cover the 70cm wires. Whilst there has not been any complaints involving a breach in sterility, Zimmer has completed a design verification to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being retrieved from the Market. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting that Customers:
1. Review the notification and ensure affected personnel are aware of the contents;
2. Assist your Zimmer Biomet sales representative by quarantining all affected product;
3. A Zimmer Biomet sales representative will remove the affected product from your facility;
4. Complete the Certificate of Acknowledgement as supplied by Zimmer;
4.a Return a digital copy to RAQA.ANZ@zimmerbiomet.com; and
4.b Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. This action has been closed-out on 17/08/2018. |
| Contact Information |
02 9483 5246 - Zimmer Biomet |