Drug recall
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality…
FDA recall event 96437 · Class II · Tornier S.A.S.
Key facts
| Event ID | 96437 |
|---|---|
| Recall numbers | Z-1534-2025, Z-1535-2025, Z-1536-2025, Z-1537-2025, Z-1538-2025, Z-1539-2025, Z-1540-2025, Z-1541-2025, Z-1542-2025 |
| Recalling firm | Tornier S.A.S. |
| Product type | Devices |
| Products | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty, stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total…, stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty, stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty, stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty and 4 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Mar 5, 2025 |
| Report date | Apr 16, 2025 |
| City | Montbonnot-Saint-Martin |
| Country | France |
| FEI number | 3000931034 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: