The Lombardi Law Firm Blog

FDA announces recall of jaw, face or cranial implants due to risk of infection

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

Welcome to the Lombardi Law Firm website. We try to make our website an interesting source of information for all people who may have suffered an injury or whose relatives have been injured or killed. We attempt to provide information that makes you more aware of how to avoid injury and death.  We are here to assist you to stay safe and with your legal problems. Call us if you have legal questions or if you have safety concerns. (515-222-1110) We are willing to assist you in finding answers to your questions and regularly write about safety measures that readers bring to our attention. Good luck on the job and be safe. Steve Lombardi is a personal injury lawyer in Iowa, but prides himself on doing more than just practicing law.  Email: sdlombardi@aol.com

If you, your spouse or a member of your family or friends are involved in any kind of accident contact the Lombardi Law Firm. We can assist you with your claim. Steve Lombardi has more than 30 years of experience in civil litigation including death and injury cases for workers and their spouses from car, semi-truck, motorcycle, pedestrian and construction accidents and injuries. We don't charge you to talk with Mr. Lombardi to find out if you have a case. Don't delay, call him today. (515-222-1110 or sdlombardi@aol.com)

Know your rights, act proactively and protect yourself.

Labels: Des Moines facial fda implants infection iowa Lombardi Stryker surgery surgical west des moines