Stryker Corp reported that it is a target of a federal grand jury probe related to the illegal promotion of human bone growth products and other issues.

The company said through a regulatory filing that it received a letter last week from the U.S. attorney's office for Massachusetts informing it of the probe.

In addition to the possible illegal promotion of the OP-1 and Calstrux products, the U.S. attorney is looking into accusations that Stryker sold misbranded medical devices and submitted false reports to the U.S. Food and Drug Administration regarding the number of patients treated with the products under humanitarian device exemptions, the company said.

Stryker had announced that it and certain current and former employees had received subpoenas from the U.S. Attorney for the District of Massachusetts.

The inquiry began last year and alleges that Stryker abused a federal exemption that authorized it to sell only limited quantities of the bone growth products for "humanitarian" reasons, according to published reports.

Last month, in a New York Times report, readers learned that two former Stryker employees had pleaded guilty to charges that they promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients.

Stryker said it was aware that former employees had pleaded guilty to charges related to the investigation. It said it was in the process of responding to the U.S. attorney's office regarding the matters. The company is not providing further comments on the probe beyond the regulatory filing.

More Voices