Plastic surgery device maker draws FDA warning letter

The agency did not rule out the possibility of including a “black box warning,” the notification it puts on its most dangerous devices to draw attention to serious risks. However, the FDA said in..

Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Whitehall, a division of Acorn Engineering Company located in the City of Industry, Calif., produces healthcare and rehabilitation equipment, including physical therapy and sports medicine products.

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A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices. According to the letter, Charlottesville-based MicroAire Surgical Instruments failed to properly explain why it grouped its Ultratine and Endotine device lines together in validating a sterilization process.

Plastic Surgery. Psychiatry. Public Health.. 2010 may have crossed in the mail with the FDA’s warning letter." The FDA letter is dated Nov. 17, 2010.. Invisalign ‘Invisible Braces’ Maker.

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Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase (augment) breast size or to rebuild (reconstruct) breast tissue after.

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7 Recent Medical Device Failures Catching FDA’s Eye.. Inadequate Sterilization for an Orthopedic Surgery Tool. The FDA is warning that a. says it has spent more than $200 million modernizing and improving its North Carolina facility in response to a 2010 Warning Letter. But still FDA says.

The warning letter was issued after an inspection held at the facility in October and November last year, and does not restrict the company’s ability to manufacture or ship products nor does it require a recall of its products, Integra Lifesciences said in a regulatory statement.

Medtronic Inc., the world’s largest device maker, commissioned. approved – such as in neck surgery. In fact, Infuse was used more often in such “off-label” procedures, researchers said. In 2008,

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"The FDA recently became aware that some healthcare providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery)," William Maisel, MD, acting director of FDA’s Office of.

The Federal Trade Commission and the Food and Drug Administration are warning. used the devices in the previous month, according to The Associated Press. The federal crackdown comes after Reuters.