Cranial Implant Kits recalled over sterility issues. Custom-made Cranial Implant Kits made by Stryker Corp. have been recalled over sterility issues. accurate
The Stryker cranial implant kit recall has been deemed a Class I recall by the 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 a Stryker press release, 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.
Sterilization validation of the product was not performed according to appropriate standards
Stryker 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.
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.
Physicians and patients with questions related to this issue
Physicians and patients with questions related to this issue should contact Stryker at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET.
Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.
Health care professionals and consumers may also report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- FAX: 1-800-FDA-0178