Tornier S.A.S.: Medical Device Recall in 2025 - (Recall #: Z-0846-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 18, 2024

Date Posted: January 22, 2025

Recall Number: Z-0846-2025

Event ID: 96030

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.

Status: Ongoing

Product Quantity: 24 units

Code Information:

UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated