Confidence Spinal Cement System Kit 의 안전성 경고

Safety alert

2013-04-19

2013-04-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130419c.html

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.