Two former sales representatives of Stryker Corp. have pleaded guilty in a Justice Department inquiry into the company. In 2008, the U.S. Attorneys office in Boston began an inquiry into Stryker, a manufacturer of medical devices. The inquiry centered around Stryker’s marketing of human bone growth products. Human bone growth products are used to help grow improperly healing bones. The FDA has not approved Stryker’s human bone growth products for widespread medical use. Instead, both products were allowed for limited use, one for broken shin and thigh bones, and the other for failed spinal fusion procedures. However, the FDA allows device makers to market their products under a "humanitarian device exemption" when it believes that a small number of people may benefit from a product that has not received full approval. The Justice Department inquiry into Stryker seeks to determine whether Stryker abused the "humanitarian device exemption" and promoted off-label use of its products. Drug and medical device manufacturers are prohibited from promoting their products for off-label or non-approved uses.
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