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

Published: 04/16/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Critical Access Hospitals,
  • Hospitals

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.  

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 thi…

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