stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in str
Summary
The FDA issued a Class II for stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, by Tornier S.A.S.. Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactor.
Details
Source
Device Recall
External ID
Z-1534-2025
Action Date
2025-04-16
Status
Ongoing
Category
device
Product Description
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 Shoulder Arthroplasty
Lot/Code Info: All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022926
Quantity Affected: 3 units
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 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.
Distribution
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-05
Company
Montbonnot-Saint-Martin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier S.A.S.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier S.A.S. have FDA actions?
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1534-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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