If you’ve had a Stryker Custom Cranial Implant surgically implanted to correct lower, upper jaw, face or cranium defects due to injury you’ll need to read the FDA Announcement and contact the surgeon who performed the surgery. You are at risk of infection.
All hospital administrators need to check supply shelves and return the kits.
If any patient needs assistance contact our office. The FDA Alert is below with the necessary link.
Stryker Custom Cranial Implant Kits
Audience: Maxillofacial surgeons, hospital risk managers
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.
Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker