Z-0846-2025 Class II Ongoing
FDA device recall Z-0846-2025 was initiated by Tornier S.A.S. on December 18, 2024 and is designated Class II. 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 potentia… The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
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.
Distribution Pattern
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Code Information
UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979