Stryker CMF's Custom Cranial Implant Kits is a Class 1 recall. The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.