Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use durin...
FDA Recall #Z-0846-2025 — Class II — December 18, 2024
Product Description
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
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.
Recalling Firm
Tornier S.A.S. — Montbonnot-Saint-Martin
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 units
Distribution
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Code Information
UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated