Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants

Stryker has issued letters notifying affected customers that certain TMJ Unilateral and Bilateral Implants have updated instructions for use.  Stryker stated that they received a report that during surgery to implant the device, a 6mm screw was placed in an approximately 2.6mm thick bone, which penetrated the cranial vault.  There is a discrepancy in the positioning of the screw hole between what was specified in the design specification sheet and the actual fossa design.  This may result in the recommended screw length being greater than the bone thickness for implants with screw holes located in an area of thin bone and penetration of the cranial vault.  Penetration of the cranial vault could lead to dural tissue damage, bleeding, cerebral spinal fluid leak (CSF), or meningitis.  Use of an affected device could require intervention to prevent serious injury.

This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold.  The FDA has identified this recall as the most serious type.  This device may cause serious injury or death if you continue to use it without following the updated instructions.

Questions?

Customers in the U.S. with questions about this recall should contact Stryker at: cmf-pfa@stryker.com.