Tornier S.A.S. recalls stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Ins…

Recall date

March 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1536-2025

FDA classification

Class II

Brand / firm

Tornier S.A.S.

Sold / distributed

US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty