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Stryker Hip Recall Update: FDA Announces Launch of New Medical Device Identification System to Better Target Recalls, Improve Patient Safety
Date:9/29/2013

New York, NY (PRWEB) September 29, 2013

The U.S. Food and Drug Administration (FDA) is launching a new system for identifying high-risk medical devices, like those affected by the Stryker hip recall (http://www.strykerhiprecall.net/) that it says will target product problems more quickly and improve patient safety, Bernstein Liebhard LLP reports.

According to an update issued September 20th on the FDA’s website, the agency has announced its plans to phase in a new unique device identification system (UDI) that will require each medical device on the market to be labeled with a unique number indicating its model, expiration date and manufacturing date.* The FDA will primarily focus on high-risk medical devices, which may include metal hip implants similar to the now-recalled Stryker Rejuvenate and ABG II modular-neck hip stems, in its program launch. The new system will allow federal regulators to efficiently identify medical devices and improve the accuracy of adverse event reports indicating possible issues with each one, the agency’s notification states.

Meanwhile, recent court records show that over 600 Stryker hip lawsuits brought by individuals who allegedly suffered pain, swelling, metallosis and other debilitating early device failure complications caused by the Rejuvenate and ABG II metal hip implants have been filed in the U.S. These devices were recalled by Stryker Orthopaedics on July 6, 2012.

“We are looking forward to see the FDA phase in this new program. We continue to hear from individuals across the U.S. who allegedly sustained injuries stemming from the Stryker hip recall,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. Right now, the Firm is offering free case evaluations for potential Stryker lawsuit claimants who may have sust
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