Recall Z-0846-2025— Tornier S.A.S.
Class II · Ongoing
Class II FDA medical device recall by Tornier S.A.S., initiated 2024-12-18. It names one FDA 510(k) clearance: K222510. Product: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.. 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..
- Recalling firm
- Tornier S.A.S.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-18
- Firm location
- Montbonnot-Saint-Martin, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.