The FDA has issued a Class 1 recall for Stryker's Custom Cranial Implant Kits because they could pose an imminent hazard to health, according to the company.
Stryker initiated a nationwide recall on October 24, 2008, after determining that the sterilization validation of the product was not performed according to appropriate standards.
Potential risks from using the product include infection (such as meningitis), intracranial abscess, wound infection, sepsis, reoperation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment.
The company recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months after the procedure.
Physicians and patients with questions related to this issue can contact Stryker at 800-962-6558, Monday through Friday, 8 a.m. to 7 p.m. Eastern time.
Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch program.
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