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Custom Cranial Implants
| Device name: | Stryker Custom Cranial Implant Kits |
| Manufacturer: | Stryker Corporation |
| Approved uses: | Custom cranial implant is designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. |
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Stryker Custom Cranial Implant Kits
Stryker’s Craniomaxillofacial (CMF) business unit announced that the U.S. Food and Drug Administration (FDA) decided on Dec. 18, 2008 that its recall of the following Stryker CMF’s Custom Cranial Implant Kits is a Class I recall, meaning the product could pose an imminent hazard to health. The FDA's announcement comes after a voluntary recall issued by the company in October of 2008, following concerns that stereilization of the implants could not be guaranteed. Implantation of contaminated devices 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 CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to the company. They will again notify hospital staff and surgeons of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.
