Tornier, Inc

FDA Regulatory Profile

Summary

Total Recalls
30
510(k) Clearances
115
Inspections
10
Compliance Actions
0

Known Names

tornier, tornier s.a.s

Recent Recalls

NumberClassProductDate
Z-1237-2026Class IITORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318December 19, 2025
Z-1738-2025Class IIBlueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder reApril 10, 2025
Z-1539-2025Class IIstryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker BluepriMarch 5, 2025
Z-1537-2025Class IIstryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker March 5, 2025
Z-1541-2025Class IIstryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyMarch 5, 2025
Z-1536-2025Class IIstryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker BlueprinMarch 5, 2025
Z-1534-2025Class IIstryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUEMarch 5, 2025
Z-1542-2025Class IIstryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder ArthroplastyMarch 5, 2025
Z-1538-2025Class IIstryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint MixeMarch 5, 2025
Z-1540-2025Class IIstryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder ArthroplastyMarch 5, 2025
Z-1535-2025Class IIstryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker BluepMarch 5, 2025
Z-1651-2025Class IIstryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; PMarch 3, 2025
Z-0846-2025Class IIStryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during TDecember 18, 2024
Z-3309-2024Class IIStryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplastAugust 29, 2024
Z-3155-2024Class IIstryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total aAugust 29, 2024
Z-1883-2024Class IIStryker Blueprint Software, Catalog #BPUE001.April 16, 2024
Z-0773-2024Class IIStryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, CementlesJanuary 3, 2024
Z-0113-2024Class IIstryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJSeptember 15, 2023
Z-2020-2023Class IIAEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118June 12, 2023
Z-2019-2023Class IIAEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101June 12, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)January 8, 2026
K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)October 30, 2025
K232265BLUEPRINT™ Patient Specific InstrumentationFebruary 21, 2024
K230352Tornier Humeral Nail and Tornier Long Humeral NailOctober 31, 2023
K222510Blueprint Mixed Reality systemJanuary 20, 2023
DEN220012Tornier Pyrocarbon Humeral HeadDecember 16, 2022
K220914Tornier Perform Humeral System – FractureOctober 14, 2022
K220418Tornier Perform Humeral System – StemlessSeptember 14, 2022
K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentNovember 12, 2021
K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresOctober 26, 2021
K203315BLUEPRINT™ Patient Specific InstrumentationApril 15, 2021
K201315PERFORM Humeral System – StemSeptember 11, 2020
K193247LATITUDE EV™ Total Elbow ArthroplastyAugust 5, 2020
K191711ORTHOLOC™ SPS Shoulder Plating SystemJuly 17, 2019
K191318AEQUALIS FLEX REVIVE Shoulder SystemJune 14, 2019
K190521Aequalis Ascend Flex Shoulder SystemJune 12, 2019
K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidJanuary 30, 2019
K182461LATITUDE EV Total Elbow ArthroplastyDecember 27, 2018
K181587ORTHOLOC SPS Shoulder Plating SystemOctober 5, 2018
K181420Aequalis Flex Revive Shoulder SystemSeptember 20, 2018