FDA recall Z-0846-2025

Tornier S.A.S. · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-12-18
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montbonnot-Saint-Martin, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2025