Reported Apr 16, 2025 · Ongoing

stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

Tornier S.A.S.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tornier S.A.S. · 161 Rue Lavoisier · Montbonnot-Saint-Martin, N/A · N/A

Is this the product you have?

  • stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Lot codes and dates
  • GTIN 03700434016505
Amount recalled
14

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.