FDA Medical devices recall ·
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide recall
- Recall number
- Z-0846-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Tornier S.A.S.
161 Rue Lavoisier, Montbonnot-Saint-Martin, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 24 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979
Distribution
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
States: Alaska Idaho Kentucky Massachusetts Maryland Minnesota Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0846-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.