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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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