Tornier S.A.S.: Device Recall

Recall Details

Recall Number

Z-1535-2025

Classification

Class II

Product Type

Device

Recalling Firm

Tornier S.A.S.

Status

Ongoing

Date Initiated

03/05/2025

Location

Montbonnot-Saint-Martin, N/A, France

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

22 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.

Product Description

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Distribution Pattern

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

Other Recalls by Tornier S.A.S.

• Class II: Risk 04/10/2025
  A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
• Class II: Risk 03/05/2025
  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: Risk 03/05/2025
  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: Risk 03/05/2025
  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: Risk 03/05/2025
  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.

View all recalls by Tornier S.A.S. →