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Tornier S.A.S.

Montbonnot-Saint-Martin, FR · 4 510(k) clearances · 13 recalls

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Total clearances
4
2021-04-15 → 2024-02-21
Last 12 months
0
Product codes
4
Most recent
2024-02-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHX Shoulder Prosthesis, Reverse Configuration Class II Orthopedic 1 2024-02-21
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2023-01-20
QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis Class II Orthopedic 1 2022-12-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Orthopedic 1 2021-04-15
Safety

Recalls (13)

Class I (serious)
0
Risk of injury / death
Total recalls
13
Currently ongoing
13
Most recent
2025-04-10
DateSeverityStatusRecall # ProductCodeReason
2025-04-10 Class II Ongoing Z-1738-2025 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. — A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
2025-03-05 Class II Ongoing Z-1542-2025 stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1541-2025 stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1540-2025 stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1539-2025 stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Ins… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1538-2025 stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1537-2025 stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Real… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1536-2025 stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1535-2025 stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality I… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2025-03-05 Class II Ongoing Z-1534-2025 stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in str… — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but i…
2024-12-18 Class II Ongoing Z-0846-2025 Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthro… — 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 una…
2024-04-16 Class II Ongoing Z-1883-2024 Stryker Blueprint Software, Catalog #BPUE001. — The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations th…
2021-06-25 Class II Ongoing Z-2291-2021 The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 … — Potential patient exposure to the graphite substrate.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-02-21 K232265 BLUEPRINT™ Patient Specific Instrumentation PHX Class II Orthopedic
2023-01-20 K222510 Blueprint Mixed Reality system OLO Class II Neurology
2022-12-16 DEN220012 Tornier Pyrocarbon Humeral Head QKW Class II Orthopedic
2021-04-15 K203315 BLUEPRINT™ Patient Specific Instrumentation KWS Class II Orthopedic
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence