Custom-made Cranial Implant Kits made by Stryker Corp. have been recalled over sterility issues. According to the Food & Drug Administration (FDA), the Cranial Implant Kits are used to correct defects in the jaw and face, or cranium and face.
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, the release said.
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. The company said it plans to repeat the notification.
Although the company demands any adverse events relating to this product should be reported to Stryker, we think it is in your best interests to contact us first.
Yes, this is old news, but if it affects you and your health, it is very current. The short version is that there may be a significant problem with your health due to medical devices. Contact the Stryker lawyers at the BISANR CHASE Personal Injury Attorneys right away if you think you have difficulties with your implant.