Lower risk Medical device recall · FDA · Published March 5, 2025

Tornier Blueprint Mixed Reality Coracoid Clamp Recall: Software and Instrumentation Issues

Tornier recalls Blueprint Mixed Reality Coracoid Clamps (MRUE202) due to software and instrumentation problems affecting shoulder surgery. Affected units were sold from August 2023 to December 2024.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1536-2025Medical device Tornier ›

Lower-risk 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.

Take action

Contact the company

Recalling firmTornier S.A.S.161 Rue Lavoisier · Montbonnot-Saint-Martin, France

✎ GovInfoNow plain-language explainer

Tornier is recalling its Blueprint Mixed Reality Coracoid Clamps (catalog number MRUE202) because users report software and hardware issues that prevent the device from working properly during shoulder surgery. This could lead to complications in surgical procedures if the device fails to function as intended. Read more at govinfonow.com/recall/52663-tornier-blueprint-mixed-reality-coracoid-clamp-recall-software-and-instrumentation.

Source Summary by GovInfoNow · govinfonow.com/recall/52663-tornier-blueprint-mixed-reality-coracoid-clamp-recall-software-and-instrumentation · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1536-2025

Cite this page

“Tornier Blueprint Mixed Reality Coracoid Clamp Recall: Software and Instrumentation Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52663-tornier-blueprint-mixed-reality-coracoid-clamp-recall-software-and-instrumentation. Based on FDA recall #Z-1536-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2025%22&limit=1).

The FDA announced on March 5, 2025, that Tornier S.A.S. is recalling the stryker Blueprint Mixed Reality Coracoid Clamp due to software and instrumentation failures that prevent intended use. The recall covers 20 units distributed in Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, Idaho, France, Canada, and Ireland.

How to tell if you have it

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202
UPC 03700434022940

The hazard

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. These issues are multifactorial but prohibit the system from meeting its intended use, with commonly reported complaints involving impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

Context

GovInfoNow's records show Tornier S.A.S. has four other recalls on record since June 25, 2021. On April 10, 2025, a recall was issued for Tornier Blueprint Software 4.2.1 due to incompatible previous cases. Other recent recalls of similar products include the Zimmer Off-Axis Shoulder System Recall (May 20, 2026) and the Olympus HX-400U-30 Ligating Device Recall (October 30, 2025).

How to tell if you have this one

Check for the catalog number MRUE202 on the clamp, which was packaged in Tornier Blueprint Mixed Reality Instrument Kits (catalog number MRUEGLN). The product was sold from August 2023 through December 2024.

Brand
Tornier
Product
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

Recall number	Product, codes & lots	Quantity
Z-1534-2025	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; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022926	3 units
Z-1535-2025	stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022933	22 units
Z-1536-2025	stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022940	20 units
Z-1537-2025	stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022957	17 units
Z-1538-2025	stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022964	51 units
Z-1539-2025	stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022971	51 units
Z-1540-2025	stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022988	474 units
Z-1541-2025	stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty; All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN x	N/A
Z-1542-2025	stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty; GTIN 03700434016505	14

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the catalog number MRUE202 on the clamp and the instrument kit catalog number MRUEGLN.

Where it went and when

Where it was distributed

Distributed in 7 states, and outside the U.S.

FDA distribution: “US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Idaho, Massachusetts, Minnesota, Pennsylvania, Tennessee, Texas.

Recall timeline

FDA published this recall 42 days after the firm started it.

Mar 5, 2025Firm started the recall
Apr 8, 2025FDA classified it Class II
Apr 16, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52663-tornier-blueprint-mixed-reality-coracoid-clamp-recall-software-and-instrumentation">Tornier Blueprint Mixed Reality Coracoid Clamp Recall: Software and Instrumentation Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1536-2025 (March 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1536-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.