Devicemaker Stryker Corp. has been hit with two new investigations, according to documents the company filed with the Securities and Exchange Commission.
On May 5, Stryker received a Food and Drug Administration warning letter related to compliance issues for a craniomaxillofacial implant product previously sold through its Portage, Mich., distribution facilities. The devicemaker is in the process of responding to the FDA’s letter, according to the SEC filing.
Stryker also received a subpoena on May 7 from the New Jersey attorney general’s office requesting documents related to financial interest and compensation of doctors participating in certain clinical trials of the company’s products. The subpoena came two days after the New Jersey attorney general’s office announced it had reached a voluntary compliance agreement with spinal-device maker Synthes over its compensation of physicians participating in clinical trials. The office then indicated that it planned to send subpoenas to five other medical-device makers requesting information on similar business practices. Names of the companies have not been released, but Stryker indicated in its filing that other devicemakers had received similar subpoenas.
Stryker spokesman Patrick Anderson said the company would not comment on the FDA warning letter or the New Jersey attorney general subpoena beyond what was supplied in Monday’s SEC filing.
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