Tornier S.A.S.: Device Recall

Recall Details

Recall Number

Z-0846-2025

Classification

Class II

Product Type

Device

Recalling Firm

Tornier S.A.S.

Status

Ongoing

Date Initiated

12/18/2024

Location

Montbonnot-Saint-Martin, France

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

24 units

Reason for Recall

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

Product Description

Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

Distribution Pattern

US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada

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. →