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zimmer knee recall, Chicago medical device liability attorneyWhen a patient undergoes surgery of any kind, they expect that they will be able to recover and move on with their life. Having to undergo surgery again because of a defective product, like Zimmer’s Persona Trabecular Metal Tibial Plate knee placement, is not in their plans. Going through recovery the first time for a knee replacement is hard enough. Having to endure through it again is unacceptable and the company who designed the defective product is responsible for product liability.

The Food and Drug Administration (FDA) issued a Class 2 recall on the product. This means that while the Persona knee replacement is used it may cause temporary or medically reversible adverse health consequences. The recall affects all sizes and lots of Persona knee replacement products for both the left and right knees.

The Persona Trabecular Metal Tibial Plate knee replacements were meant to be used without cement and still adhere to the bone. Complaints from patients found that the knee replacement became loose or caused radiolucent lines or gaps between the bone and knee replacement. The gaps can fill with fluid or debris and cause more health issues. In all cases, patients complained of increased pain and some cited increased immobility.

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infant medical device recall, Chicago product liability attorneyPhilips Healthcare initially recalled its Gel-E Donut and Squishon 2 medical devices in May 2014 after visible mold was detected on the outer surface of the products. This recall was for devices distributed from July 2012 to December 2013.

As of October 2014, the Food and Drug Administration (FDA) reported a Class I recall issued by the same manufacturing company for the same devices. These gel-filled products are used under supervision in hospitals to support an infant’s head and body. The following models have been recalled:

  • Gel-E Donut 92025-A;
  • Gel-E Donut 92025-B;
  • Gel-E Donut 92025-C; and
  • Squishon 2 91033-2.

The second recall included products manufactured from July 2012 through to August 2014. The defective devices prompted 12 new complaints of visible mold within just four months of the initial recall. Cladosporium and Penicillium Fungi were two of the molds identified, which can cause:

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Chicago medical device recall lawyerPatients rely on hospitals to ensure that safety protocols and education for medical staff are current and privy to any changes regarding medical device recalls. For over 45 years, ECRI has helped in this effort by focusing on improved patient care by studying the effectiveness of medical products, procedures, and processes. Based on an article published by Modern Healthcare, ECRI experts reveal certain hospitals are failing to update their medical device recall programs to meet today’s standards.

Over 1,000 medical device recalls were reported by the Food and Drug Administration in 2012, a figure almost doubling the number reported nearly a decade previous. The number and complexity of recalls have increased over the years, which carries concerns regarding hospital efficiency in tracking its defective products.

A Medical Equipment Management Plan issued by the Joint Commission has issued standards for hospitals to:

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