Stryker CMF Recalls Defective Custom Cranial Implant Kits

Medical technology developer Stryker CMF has issued a voluntary recall of its custom cranial implant kits following reports of inadequate sterilization practices. Stryker issued the recall on October 24, 2008, listing cranial implant kits with catalogue numbers 54-00101, 54-00102, 54-00103 and 54-00104 as those likely affected by negligent production.

Stryker CMF demands that production of its medical devices follow strict sterilization guidelines. The recall was issued because the company deemed that “sterilization validation” of the aforementioned cranial implant kits was not performed in accordance with Stryker standards.

Although the recall was issued voluntarily, the Food and Drug Administration (FDA) weighed in on December 18, 2008, labeling the recall as class 1. This means that the recalled product has been deemed capable of causing serious harm or death. The class 1 label also means that the FDA would have sought a recall even if Stryker had not voluntarily issued one.

Injuries Associated with Defective Cranial Implant Kits

A number of injuries may result from the implantation of a medical device that has not been properly sterilized during production. Some of the potential injuries identified by Stryker include:

  • Infection (meningitis)
  • Intracranial abscess
  • Sepsis
  • Neurological problems

These injuries could result in additional hospitalization and/or long-term intravenous antibiotic treatment. In the most serious of cases, injuries could result in death.

Physicians and hospitals carrying the defective Stryker implant kits have been alerted to discontinue use and return potential hazardous devices to Stryker immediately.

Cranial Implant Kit Lawsuits

If you or a loved one has been injured as a result of a defective Stryker cranial implant kit, you may be entitled to compensation. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them. Failure to adequately measure the potential for medical device failure, side effects or long term problems associated with use of a medical device is considered negligent and may be grounds for litigation.

The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact AWKO Law today at (844) 794-7402 to get more information about your rights as a victim of negligence.