Medical Devices Calss Action Lawsuits , Recalls and Defects
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The FDA has expanded its recall of the hernia mesh patch designed by Dr. Robert D. Kugel and manufactured by Davol, Inc. (a subsidiary of C.R. Bard). The FDA sent a letter to health care professionals and distributors on January 10, 2007 notifying them of the most recent expansion of the recall
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The implantable hip device is manufactured by Zimmer Holdings. The Zimmer hip, has received complaints from surgeons and patients who state that the design is flawed causing many patients to undergo revision hip surgery.
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Stryker Corporation has issued a temporary recall of its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. The recall was issued one week after teh US FDA issued a warning letter about defects in the manufacturing processes at its Mahwah, New Jersey plant.
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Medtronic reported that, as of October 4, 2007, there were approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 in the United States. Of the 268,000, about 235,000 patients still have the leads. Medtronic revealed that lead fractures may have been a possible or likely contributing factor in five patient deaths.
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