Events

Recall of Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System) Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00849-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00849-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis Syst...
  • Model / Serial
    Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System)Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mmPart Number: 04.670.955SLot Number: 9736836ARTG Number: 133399
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes