Custom Cranial Implant Kits manufactured and sold by Stryker Corp. have been recalled due to a risk that the products may not be sterile and could pose a risk of serious and potentially life-threatening infections for individuals who received the implants to correct traumas or defects in the jaw and face or cranium and face.
The Stryker Custom Cranial Implant recall was issued on December 24, 2008 for small, medium, large and extra large size kits, which were distributed and used since November 5, 2007.
Stryker indicates that they can not be assured that the products are sterile, so implanting surgeons have been notified to return any remaining kits and to follow up with patients about possible infections for at least six months after surgery.
The kits are custom designed for each patient and could be used to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face.
According to a press release issued by Stryker Corp, implantation of unsterile products “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.”
Physicians have been advised to closely monitor their patients for signs of infection, as death can occur if an infection is not diagnosed and treated quickly.
Stryker Corp. has had a number of manufacturing problems this year which have impacted their medical devices and resulted in recalls.
In January 2008, a Stryker Trident hip recall was issued for certain components manufactured at their plant in Ireland. The hip implant parts were found to deviate from manufacturing specifications, which could potentially cause premature loosening of the parts, hip replacement infections or other serious problems.
In September 2008, Stryker recalled approximately 26,000 of their System 6 surgical power tools after discovering that the medical devices could develop a sticky trigger after a number of uses.
Last month, Stryker Corp. indicated that they intend to spend at least $50 million more annually over the next three years to improve their quality control systems and address the manufacturing problems they have had.