Tornier S.A.S.
Tornier S.A.S. holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2024, with 13 FDA device recalls on record.
Top product codes for Tornier S.A.S.
FDA recalls by Tornier S.A.S.
10 most recent of 13- Z-1738-2025 — Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
- Z-1541-2025 — stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1535-2025 — stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1537-2025 — stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1540-2025 — stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
- Z-1539-2025 — stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1542-2025 — stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
- Z-1536-2025 — stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1538-2025 — stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Z-1534-2025 — stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tornier S.A.S.
- K232265 — BLUEPRINT Patient Specific Instrumentation
- K222510 — Blueprint Mixed Reality system
- DEN220012 — Tornier Pyrocarbon Humeral Head
- K203315 — BLUEPRINT Patient Specific Instrumentation
- K190521 — Aequalis Ascend Flex Shoulder System
- K162800 — BLUEPRINT Patient Specific Instrumentation
- K161789 — BLUEPRINT Patient Specific Instrumentation
- K153452 — Salto XT, Salto Talaris
- K160555 — BLUEPRINT Patient Specific Instrumentation
- K152966 — Aequalis Fx2
- K151293 — Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
- K143374 — BLUEPRINT Patient Specific Instrumentation
- K141345 — AEQUALIS FX2
- K140478 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K140082 — AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
- K132285 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K131231 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
- K130051 — 611 ANKLE FUSION NAIL
- K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
- K122698 — AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.