[Recalled] stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty — Stryker identified an elevated complaint
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty |
|---|---|
| Brand / manufacturer | Tornier S.A.S. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1535-2025 |
| Country of notice | France |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 March 2025 |
| EAN / barcode | 03700434022933 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in France and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Tornier S.A.S.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.