Stryker Craniomaxillofacial Issues Nationwide Recall on its Custom Cranial Implant Kits
FDA -Wednesday, December 24, 2008

This recall was issued after determining that the sterilization validation of the product was not performed according to appropriate standards.

FDA Announces Class I Recalls of Two Unapproved Devices
FDA -Monday, December 15, 2008

The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.