Sterility problems have prompted Stryker Corp. to issue a Class I recall of its Custom-made Cranial Implant Kits. The Stryker cranial implant kit recall has been deemed a Class I recall by the Food & Drug Administration (FDA_.  Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death, the agency said.

According to the FDA, the Cranial Implant Kits are used to correct defects in the jaw and face, or cranium and face. In a press release, Stryker said it issued the recall  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, Stryker said.

The recall involves 322 Custom Cranial Implant Kits.  The kits included in the recall are Small (Catalog no. 54-00101), Medium (Catalog no. 54-00102), Large (Catalog no. 54-00103), and Extra large (Catalog no. 54-00104) sizes.  Stryker recalled all kits it distributed between Nov. 5, 2007, and Oct. 23, 2008, the release said.

Physicians and hospitals should stop implanting the Cranial Implant Kits immediately and return them to Stryker. According to the Stryker press release, patients who have received these implants should be monitored by their physicians for signs of infection for at least six months post-implantation.

Stryker said it previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits via a letter dated Oct. 24,  and requested that they return any remaining products.  The company said it plans to repeat the notification.