Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Stryker recall: An Oct. 24-initiated recall of 322 Stryker Custom Cranial Implant Kits is Class I, the most serious category, FDA says Dec. 24. The kits were not sterilized according to proper standards, Stryker stated, and therefore may cause serious health problems including infection, intracranial abscess, sepsis, neurological deterioration and even death. Hospitals and company reps have been notified and physicians should stop implanting the product and monitor implanted patients for signs of infection. The kits were distributed from Nov. 5, 2007, through Oct. 23, 2008. On Nov. 20, 2008, FDA sent a 1warning letter to Contract Medical Manufacturing, which makes custom implants for Stryker, for problems with its sterilization process