Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants
Stryker is updating the Instructions for Use (IFU) for its patient-fitted TMJ Unilateral and Bilateral Implants to address a technical discrepancy regarding the positioning of the screw hole.
This update affects Stryker, healthcare providers utilizing patient-fitted TMJ reconstruction prostheses, and surgical teams responsible for the implantation of these devices.
A discrepancy in screw hole positioning instructions may lead to intraoperative challenges or improper fixation if surgeons rely on inaccurate technical documentation. This correction suggests a need for heightened precision in the labeling of patient-specific (custom) devices, where alignment between the device design and the instructions for placement is critical for intended clinical performance.
Quality and Regulatory departments should ensure that all clinical users are notified of the manual updates and confirm that surgical planning protocols account for the screw hole positioning discrepancy. Internal inventory and distribution records should be audited to verify that the most current Instructions for Use (IFU) accompany these patient-fitted implants.
Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole.
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