| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00849-1 |
| Product Name/Description |
Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System)
Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm
Part Number: 04.670.955S
Lot Number: 9736836
ARTG Number: 133399 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Prodisc-C Vivo implants are packaged sterile in a double barrier setup, with an outer foil package and an inner blister package. For the impacted lot, the Tyvek lid may be missing from the inner blister package. Manufacturer’s assessment has identified that due to the double barrier sterile packaging, the sterility of the implants will continue to be maintained when the Tyvek lid is missing.
The packaging non-conformance has the potential to result in intraoperative surgical delay. When the outer foil pouch package is opened, the implant may dislodge from the uncovered blister package and has the potential to fall outside of the sterile field. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are advised to inspect stock and quarantine any remaining product for return to Johnson and Johnson. Patients who are implanted with the affected stock should be monitored in accordance with standard practice for the Prodisc-C Vivo treatment process.
This was closed out on the 11/09/2018 |
| Contact Information |
02 9815 4698 - Johnson & Johnson Medical |