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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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medical device recall, medical product liability lawyerIn an executive summary of its Medical Device Recall Report, the FDA revealed that the annual number of recalls increased by a staggering 97 percent from 2003 to 2012. Over the past decade, the complexity of medical device recalls increased and 1,190 recalls were reported in 2012, almost double the amount in 2003. Manufacturers maintain product liability for devices they market and have a responsibility to the public to alert of any potential hazards.

The FDA categorizes recalls into one of three classes. Class II recalls reflected the most significant increase in the recall report with a reported 1,043 recalls in 2012, up from 460 a decade ago.

The largest single-day recall occurred last August when Customed, a surgical kit provider out of Puerto Rico, recalled 233 of its products due to sterility issues. Other medical device recalls, such as metal-on-metal hip implants, have led to thousands of patients being affected and billions of dollars in lawsuits against its manufacturers.

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FDA product recalls, Chicago product liability lawyerThe FDA has instituted a final guidance document in order for companies to clearly distinguish a recall from a market withdrawal. Part of the draft version of the new guidance called for reporting of any enhancement of a product, a factor critical when determining potential health risks and dangers to consumers.

Many in the medical device industry were concerned about additional paperwork rather than focusing on the importance of detailed documentation for the benefits of safety. Certain devices have been approved for market that have represented an upgrade, innovation, or correction to a previous device and have resulted in recalls.

It is a manufacturer’s responsibility to find the original source of the problem and not look at a defect as an isolated incident. One of the main intentions of the new guidance is to clarify when a change to a device constitutes a product recall. One example states, “a change to a marketed device to address false or misleading labeling or other labeling violations would generally constitute a medical device recall.”

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