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zimmer knee implant recallZimmer voluntarily started recalling their Persona Trabecular Metal Tibial Plate knee replacement system in March. The Federal Drug Administration (FDA) issued a Class II recall for all makes and sizes. Companies are responsible for providing product liability for any product they produce and sell.

The FDA Class II Recalls are an intermediate level of concern. There is no immediate danger of death or serious injury, but there is still a possibility if the product’s use is continued. There are also still health and safety concerns. The FDA works with the manufacturer to help patients affected by the product recall to ensure the product is taken off the market as soon as possible.

In the case of Zimmer, they started recalling their Persona Trabecular Metal Tibial Plate system on their own, but not fast enough for the FDA. Complaints started increasing concerning implants loosening and causing complications. Over 11,500 devices are affected by the recall. The Persona system is not the first recall Zimmer has experienced. Two other products they have produced in the past have recently been recalled and taken off the market for similar complaints of the devices loosening. How can a company continue to be trusted to produce products if their products continue to be recalled for similar issues among different devices?

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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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