Tornier S.A.S. Recall 96437
Description: stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Tornier S.A.S. Recall 96437 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1535-2025 |
| Event ID | 96437 |
| Event Description | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty |
| Product Type | Devices |
| Distribution | US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland |
| Quantity | 22 units |
| Recall Reason | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. |
| Device Classification | 20250416 |
| Device Code Info | All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022933 |
| Center Classification Date | 20250408 |
| Recall Initiation Date | 20250305 |
| Recalling Firm | Tornier S.A.S. |
| Initial Notification | |
| Similar To |