FDA Medical devices recall ·
stryker Blueprint Mixed Reality Box Base recall
- Recall number
- Z-1538-2025
- Date
- (initiated March 5, 2025)
- Company / brand
- Tornier S.A.S.
161 Rue Lavoisier, Montbonnot-Saint-Martin, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 51 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022964
Distribution
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
States: Alaska Idaho Massachusetts Minnesota Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1538-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.