• Temporomandibular joint (TMJ) jaw problems
• Birth defects
• Traumatic brain injury
• Other skull or face injuries
• Plastic surgery
Custom cranial implants are designed individually for each patient to correctly fit the lower jaw, upper jaw, face, or skull.
When the FDA approved Stryker CMF Custom Cranial Implant Kit in March 2005, the kit was approved as a non-sterile device. Hospitals were responsible for making sure the devices were sterilized prior to use. However, in October 2007, Stryker began labeling and marketing the devices as sterile. This meant that although not approved as a sterile device, Stryker was solely responsible for ensuring the sterility of these products.
In September 2009, the FDA investigated Stryker’s manufacturing facility. They found that Stryker’s manufacturing practices violated at least nine different federal safety regulations. As a result, Stryker could not guarantee the sterility of the Custom Cranial Implant Kits.
A Class I recall was issued; this means that the product could pose an imminent hazard to the health of users. Physicians and hospitals carrying the defective Stryker implant kits were alerted to discontinue use and return potential hazardous devices to Stryker immediately.
Implantation of the recalled devices could result in serious health problems, including:
• Wound infection
• Intracranial abscess
• Revision of cranioplasty
• Long-term neurological problems
• Additional surgery
• Additional hospitalization
• Long-term intravenous antibiotic treatment
• Wrongful Death
Cranial implant kits with catalog numbers 54-00101, 54-00102, 54-00103 and 54-00104 were determined to be the most likely to be affected by the safety violations.
Stryker suggested that patients who received the cranial implants be monitored by their physicians for signs of infection for at least six months after implantation.
Have You Or A Loved One Been Injured By A Defective Medical Device?
If you or a loved one has been injured by a defective medical device you need to speak with an experienced defective medical device attorney as soon as possible. Please contact us online or call our Kansas City office directly at 816.471.5111 to schedule your free consultation.