{"id":5946,"date":"2012-12-04T16:54:40","date_gmt":"2012-12-04T21:54:40","guid":{"rendered":"http:\/\/localhost:10028\/practiceareas\/new-york-zimmer-biomet-bone-growth-spinal-fusion-stimulator-lawyers\/"},"modified":"2022-06-21T16:54:56","modified_gmt":"2022-06-21T20:54:56","slug":"new-york-zimmer-biomet-bone-croissance-spinal-fusion-avocats","status":"publish","type":"practiceareas","link":"https:\/\/napolilaw.lemonadestand.org\/fr\/domaines-de-pratique-2\/new-york-zimmer-biomet-bone-croissance-spinal-fusion-avocats\/","title":{"rendered":"Zimmer Biomet Bone Growth and Spinal Fusion Stimulator"},"content":{"rendered":"

En novembre 2018, la Food and Drug Administration a mis \u00e0 niveau un rappel ant\u00e9rieur du stimulateur de croissance osseuse et de fusion vert\u00e9brale Zimmer Biomet vers un rappel de classe I. La FDA ne prend cette mesure que s'il existe une probabilit\u00e9 raisonnable que l'utilisation ou l'exposition \u00e0 un produit en infraction causera cons\u00e9quences n\u00e9fastes graves pour la sant\u00e9 ou d\u00e9c\u00e8s<\/a>.\u201d Issues with the Bone Growth\/Spinal Fusion Stimulator mainly include a lack of validation which can cause serious, and possibly fatal, bacterial infections.<\/p>\n

This latest recall is just the latest in a strong of difficulties for Zimmer Biomet and the entire medical device industry. In 2017, a study linked cheap foreign components in hip implants with l\u00e9sions c\u00e9r\u00e9brales<\/a>. As a result of these supply chain problems and other challenges, Zimmer Biomet\u2019s CEO resigned.<\/p>\n

FDA officials knew about the Bone Growth\/Spinal Fusion Stimulator\u2019s issues for almost a year before they issued a recall. When government bureaucrats refuse to protect consumers, the assertive attorneys at Loi de Naples<\/a> se tenir dans l'\u00e9cart. Nous retroussons nos manches et recueillons des preuves \u00e0 l'appui de votre demande de dommages-int\u00e9r\u00eats. Ensuite, nous pr\u00e9sentons un cas convaincant devant le tribunal. Gr\u00e2ce \u00e0 notre expertise, la plupart de nos dossiers de dispositifs m\u00e9dicaux d\u00e9fectueux se r\u00e8glent \u00e0 l'amiable. Les grandes entreprises de dispositifs m\u00e9dicaux ont peur de notre \u00e9quipe juridique, et nous utilisons ce fait \u00e0 votre avantage.<\/p>\n

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Qu'est-ce que le stimulateur de croissance osseuse\/fusion vert\u00e9brale zimmer biomet ?<\/h2>\n

This device uses small electrical impulses to stimulate bone growth. Doctors typically use the Bone Growth\/Spinal Fusion Stimulator to facilitate faster recovery from spinal fusion surgery or a serious broken bone. This gadget may have some off-label uses as well, most notably in certain kinds of dental procedures.<\/p>\n

In 2017, the FDA began receiving complaints from patients who had this device implanted and experienced severe bacterial infections. But rather than take action, the FDA did nothing. Instead, it allowed Zimmer\/Biomet to issue a voluntary recall in February 2018.<\/p>\n

Two months later, FDA officials re-inspected the company\u2019s Bone Growth\/Spinal Fusion Stimulator production facility, and they were aghast at what they found. The company had apparently done little or nothing to correct the flaws in the manufacturing process. Zimmer Biomet officials said the problems were a \u201cmisunderstanding\u201d and promised further corrective action. Rather unsurprisingly, that action did not materialize.<\/p>\n

Nevertheless, the FDA waited another six months to issue a recall. That notice was backdated to Bone Growth\/Spinal Fusion Stimulator which hit the market beginning in 2015. So, anyone who received a Zimmer Biomet Bone Growth\/Spinal Fusion Stimulator between 2015 and 2018 is at risk for serious injury.<\/p>\n

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Infections bact\u00e9riennes m\u00e9dicales courantes<\/h2>\n

There is little anyone can do about sporadic, one-off bacterial infections. Understandably, manufacturers may not be liable for damages in these situations. But a chronic lack of oversight is a different matter. If the device is defective, people get hurt, and the company does nothing, liability may attach as outlined below.<\/p>\n

The bacterial infections which result from a lack of control can cause serious and fatal conditions. The most common types of device-related infections are:<\/p>\n