Stryker’s biotech unit is under US review

Stryker Corp. said its biotech unit is being investigated by a US grand jury over illegal product promotion, the sale of misbranded medical devices, and the submission of false reports to US regulators.

Stryker, the third-largest maker of artificial knees and hips, was informed of the probe in a March 5 letter from the US attorney’s office for the district of Massachusetts, the company said in a regulatory filing yesterday.

The company said the investigation relates to its OP-1 products, a protein that promotes bone growth, and Calstrux bone filler. Stryker, based in Kalamazoo, Mich., said former employees have pleaded guilty to charges related to the investigation and that current and former employees have been subpoenaed.

Food and Drug Administration spokeswoman Karen Riley said the agency doesn’t comment on pending litigation, and would not confirm the charge that Stryker Biotech, which is based in Hopkinton, Mass., had submitted false reports. A Stryker spokesman didn’t return a phone call left after business hours.

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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