CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
stryker Blueprint Mixed Reality Box Base recalled by Tornier S.A.S
Tornier S.A.S is recalling stryker Blueprint Mixed Reality Box Base, distributed in 7 states. The recall was initiated on 5 Mar 2025 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-1538-2025
- FDA event ID
- 96437
- Recalling firm
- Tornier S.A.S, Montbonnot-Saint-Martin, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Mar 2025
- FDA classified
- 8 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 5 Mar 2025 | Recall initiated by company | |
| 8 Apr 2025 | Classified by FDA | +34 days |
| 16 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Where it was distributed
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Questions about this recall
Is stryker Blueprint Mixed Reality Box Base recalled?
Yes. Tornier S.A.S recalled stryker Blueprint Mixed Reality Box Base on 5 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1538-2025.
Why was it recalled?
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Which lots are affected?
All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022964
Where was it sold?
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
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 21 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 | Packaging Defects | 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 | Packaging Defects | 7 states |
| Device | CLASS II | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide recalled | Tornier S.A.S | Foreign Material | 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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |