BiologicsExtremitiesHospitalsNeuroReconSpineSports Medicine

Stryker Says One Of Four FDA Warning Letters Now Resolved

Stryker Corp. (SYK) has resolved one of four warning letters issued by the Food and Drug Administration in recent years due to issues found at company plants, the medical device-maker said Tuesday.

The resolved letter was issued to the company’s Biotech division in 2008 regarding a Massachusetts plant where Stryker makes a product that promotes bone growth. Issues cited by the FDA included falsification of hospital-approved documents under an FDA rule that allows device sales on a very limited basis.

While Stryker still has three more letters to address, resolving the Biotech issue is “an important first step” toward the company’s goal of full resolution, Stryker Chief Executive Stephen P. MacMillan said on a conference call following the company’s third-quarter earnings release.

He announced on the call that the letter was resolved following an FDA re- inspection earlier this year.

Shares of the Kalamazoo, Mich., company traded up 3.4% to $46.80 after hours on Tuesday after slipping 1.9% during regular trading.

Tags

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.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button