CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide recalled
Tornier S.A.S is recalling Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, distributed in 7 states. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0846-2025
- FDA event ID
- 96030
- Recalling firm
- Tornier S.A.S, Montbonnot-Saint-Martin
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +23 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Where it was distributed
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Questions about this recall
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.
Which lots are affected?
UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979
Where was it sold?
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Tornier S.A.S
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Blueprint Software, BPUE001. Intended for use by surgeons as a pre recalled | Tornier S.A.S | Device Malfunction | Nationwide |
| Device | CLASS II | stryker Blueprint Mixed Reality Glenoid Box Lid recalled | Tornier S.A.S | Device Malfunction | 7 states |
| Device | CLASS II | stryker HoloBlueprint Application recalled by Tornier S.A.S | Tornier S.A.S | Device Malfunction | 7 states |
| Device | CLASS II | stryker Blueprint Mixed Reality Instrument Check Block recalled | Tornier S.A.S | Device Malfunction | 7 states |
| Device | CLASS II | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide recalled | Tornier S.A.S | Device Malfunction | 7 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |