Device product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Z-0846-2025
Product summary
- Firm
- Tornier S.A.S.
- Event
- Event 96030
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0846-2025
Official wording
Reason: 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.
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
Derived failure modes
-
Unknown
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.