Friday, December 26, 2008

FDA Recalls Custom Stryker Cranial Implant Kits

Stryker has had an interesting 2008. Pain pumps made by that company have been the subject of litigation. (The Stryker Pain Pumps are infusion devices designed to deliver controlled amounts of local anesthetics to the patient for post-operative pain management. Medication is delivered directly to the surgical wound site or in close proximity to the nerves associated with the surgical area. The pump infuses the medication at an hourly flow rate or combination of an hourly flow rate and controlled bolus doses.)

It also made news because of it was claimed to have been been running illegal ads that a group alleged violated some U.S. Food and Drug Administration (FDA) requirements. Source here.

Now there is this news: The FDA has issued a class 1 recall for Stryker Custom Cranial Implant Kits, manufactured by Stryker Leibinger USA, because of lack of assurance of sterility and risk for infection, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. Class 1 recalls warn of situations in which there is a reasonable probability that use of the recalled products will cause serious injury or death.

The recall affects all sizes of the cranial implant kit distributed from November 5, 2007, through October 23, 2008. These custom implants are individually designed to correct patient-specific trauma-related and/or other defects of the lower jaw (mandibular), upper jaw, and face (maxillofacial), or the cranium and the face (craniofacial bone).

A letter dated October 24, 2008, notified sales representatives, risk managers, implanting surgeons, and other appropriate healthcare professionals of the recall, stating that sterility could not be assured and that there was a risk for serious infections. In addition, clinicians were advised to follow up with patients for infections for at least 6 months after surgery, and instructions were provided for identifying and returning any remaining implant kits.

Source here.