{"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":"nowy-jork-zimmer-biomet-bone-growth-spinal-fusion-stymulator-prawnicy","status":"publish","type":"practiceareas","link":"https:\/\/napolilaw.lemonadestand.org\/pl\/teren-do-cwiczen-2\/nowy-jork-zimmer-biomet-bone-growth-spinal-fusion-stymulator-prawnicy\/","title":{"rendered":"Zimmer Biomet Bone Growth and Spinal Fusion Stimulator"},"content":{"rendered":"

W listopadzie 2018 r. Agencja ds. \u017bywno\u015bci i Lek\u00f3w podnios\u0142a poziom wycofania wcze\u015bniejszego stymulatora wzrostu ko\u015bci i rdzenia kr\u0119gowego firmy Zimmer Biomet do klasy I. FDA podejmuje takie dzia\u0142anie tylko wtedy, gdy \u201eistnieje uzasadnione prawdopodobie\u0144stwo, \u017ce u\u017cycie lub nara\u017cenie na produkt naruszaj\u0105cy przepisy spowoduje powa\u017cne niekorzystne konsekwencje zdrowotne lub \u015bmier\u0107<\/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 urazy m\u00f3zgu<\/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 Prawo Neapolu<\/a> sta\u0107 w szczelinie. Zakasamy r\u0119kawy i zbieramy dowody potwierdzaj\u0105ce Twoje roszczenie o odszkodowanie. Nast\u0119pnie przedstawiamy przekonuj\u0105c\u0105 spraw\u0119 w s\u0105dzie. Dzi\u0119ki naszemu do\u015bwiadczeniu wi\u0119kszo\u015b\u0107 spraw dotycz\u0105cych wadliwych urz\u0105dze\u0144 medycznych rozstrzygana jest poza s\u0105dem. Du\u017ce firmy produkuj\u0105ce urz\u0105dzenia medyczne boj\u0105 si\u0119 naszego zespo\u0142u prawnego, a my wykorzystujemy ten fakt na Twoj\u0105 korzy\u015b\u0107.<\/p>\n

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Co to jest stymulator wzrostu ko\u015bci\/zrostu kr\u0119gos\u0142upa firmy 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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Powszechne medyczne infekcje bakteryjne<\/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