FDA-Device2025-01-22Class II
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Tornier S.A.S.
Hazard
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.
Sold states
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Affected count
24 units
Manufactured in
161 Rue Lavoisier, Montbonnot-Saint-Martin, France
Products
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2025Don't want to check this manually?
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