| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00897-1 |
| Product Name/Description |
Application Instrument for Sternal ZIPFIX
(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)
Product Number: 03.501.080
Multiple Lot Numbers (see attached)
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
In the affected lots of the Application Instrument for Sternal ZIPFIX :
· The end cap may loosen, thus reducing the tension applied to the implant.
· The end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional.
If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. If the tension coil spring detaches completely from the ZIPFIX Application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. If the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. No such occurrence has been reported to date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are requested to immediately check their inventory to determine if the facility has any affected product and if so to quarantine those units prior to returning them to JJM for repair. This action has been closed-out on 05/09/2016. |
| Contact Information |
1300 562 711 - DePuy Synthes Customer Service |