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U.S. Department of Health and Human Services


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Stryker Custom Cranial Implant Kits

Audience: Maxillofacial surgeons, hospital risk managers

[Posted 12/24/2008] 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.

[December 23, 2008 - Press Release - Stryker]
[December 23, 2008 - Recall Notice - FDA]