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The FDA has recalled some Stryker Custom Cranial Implant Kits due to uncertainty regarding the sterility of the products. A voluntary recall was initiated by Stryker in October of 2008, and the official FDA recall, Class 1, came this week. Proper sterilization testing was not completed on kits distributed between November 2007 and October 2008. Patients who receive improperly sterilized implants could experience infection such as meningitis, intracranial abscess…

…wound infection, sepsis, long-term neurological deterioration, and other severe medical conditions. Stryker suggests patients with these implants be monitored by a physician for six months following the initial surgery. See the ADA website for more on this topic.