08
Apr
2025

FDA Recall: Impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

,
0

Company: Tornier S.A.S.
Date of Enforcement Report: 4/8/2025
Class II

PRODUCT

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.

Recall Number:

Z-1534-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Tornier S.A.S.

VOLUME:

3 units

DISTRIBUTION:

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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