Events

Safety Alert for Confidence Spinal Cement System Kit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by DePuy Synthes Spine.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-04-19
  • Event Date Posted
    2013-04-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130419c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: depuy synthes confidence spinal cement system kit medical device manufacturer, depuy synthes spine has issued a field safety notice concerning confidence spinal cement system 7cc kit [2839-07-000], confidence spinal cement system 11cc plus kit [2839-10-000], confidence spinal cement system kit [2839-13-000] with the following lot numbers: confidence spinal cement system 7cc kit: hpbbwt, hpdbfy confidence spinal cement system 11cc plus kit: hpbb0k, hpbb3c, hpcb7j, hpdbd6, hpbb0l, hpbb3d, hpcb7w, hpdbf0, hpbb0m, hpbb3f, hpdbbc, hpdbg4, hpbb0n, hpbbwh, hpdbbd, hpdbgb, hpbb0p, hpbbwj, hpdbbk, hpdbgc, hpbb0t, hpbbwl, hpdbbl, hpdbgj, hpbb19, hpbbz8, hpdbby, hpdbgm, hpbb27, hpbbzd, hpdbcd, hpdbgn, hpbb29, hpbbzn, hpdbcf, hpdbgy, hpbb2b, hpcb7b, hpdbd0, hpbb2c, hpcb7c, hpdbd3, hpbb2g, hpcb7h, hpdbd4 confidence spinal cement system kit: hpbb0b, hpbbwm, hpcb75, hpccbn, hpbb0r, hpbbwp, hpcb7d, hpdbbv, hpbb28, hpbbz7, hpcb7f, hpdbcg, hpbb2d, hpbbzf, hpcb7t, hpdbd1, hpbb2f, hpbckh, hpcb7v, hpdbd5, hpbb4r, hpbdl9, hpcb8g, hpdbf9, hpbbv1, hpcb67, hpcblc, hpdbgh, hpbbwg, hpcb68, hpcbm1, hpdbgk, hpbbwk, hpcb74, hpccbm, hpdbgl according to the manufacturer, complaints have been received involving product currently in distribution in which the customer reports that during injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement. this could result in surgical delay in order to prepare another kit or termination of the procedure earlier than intended which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the manufacturer advises users to remove the affected products from service and contact the local supplier to arrange product return, credit, and/or replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

Device

Confidence Spinal Cement System Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: DePuy Synthes Confidence Spinal Cement System Kit
  • Manufacturer
    DePuy Synthes Spine

Manufacturer

DePuy Synthes Spine