Stryker Blueprint Mixed Reality Instruments Recalled for System Failures

Summary

Tornier S.A.S. is recalling 652 units of Stryker Blueprint Mixed Reality surgical instruments, which are used during total shoulder replacement surgeries. The recall includes various components such as pin guides, digitizers, clamps, and the associated HoloBlueprint software application. The manufacturer identified an elevated rate of complaints involving software malfunctions and mechanical failures that prevent the system from working correctly during surgical procedures. While no injuries have been reported, these failures prevent the system from meeting its intended use.

Risk

The system failures—including impaired software and instrumentation functioning—can prevent the guidance system from performing as expected during surgery. This poses a risk of surgical delays or the need for surgeons to switch to alternative methods or instruments, though no specific patient injuries have been confirmed to date.

Additional Information