Tornier, Inc.
Tornier, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2026, with 18 FDA device recalls on record.
Top product codes for Tornier, Inc.
FDA recalls by Tornier, Inc.
10 most recent of 18- Z-1769-2026 — Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
- Z-1237-2026 — TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Z-1651-2025 — stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
- Z-3309-2024 — Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
- Z-3155-2024 — stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
- Z-0773-2024 — Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
- Z-0113-2024 — stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Z-2019-2023 — AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
- Z-2020-2023 — AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- Z-1216-2022 — Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
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, Inc.
- K260721 — Tornier Perform Advanced Glenoid
- K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail
- K220914 — Tornier Perform Humeral System Fracture
- K220418 — Tornier Perform Humeral System Stemless
- K211359 — Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation
- K213124 — Tomier Perform Reversed Glenoid Cannulated Glenospheres
- K201315 — PERFORM Humeral System Stem
- K193247 — LATITUDE EV Total Elbow Arthroplasty
- K191711 — ORTHOLOC SPS Shoulder Plating System
- K191318 — AEQUALIS FLEX REVIVE Shoulder System
- K183696 — Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
- K182461 — LATITUDE EV Total Elbow Arthroplasty
- K181587 — ORTHOLOC SPS Shoulder Plating System
- K181420 — Aequalis Flex Revive Shoulder System
- K171010 — Latitude EV Total Elbow Arthroplasty
- K161742 — Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
- K160975 — Aequalis PerFORM+ Shoulder System
- K150871 — ForeFoot STP System
- K150715 — 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
- K150583 — Aequalis PerFORM+ Shoulder System
- K143552 — Simpliciti Shoulder System
- K141029 — TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
- K133777 — TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
- K133376 — AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
- K132632 — TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
- K122635 — TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
- K130422 — PHANTOM FIBER BIOFIBER SUTURE
- K122487 — BIOFIBER SYTURE
- K120262 — HLS UNI EVOLUTION & U-KNEETEC
- K120739 — AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
- K121493 — ASCEND SHOULDER SYSTEM
- K120794 — ASCEND SHOULDER SYSTEM
- K113413 — ASCEND SHOULDER SYSTEM
- K111337 — TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
- K112615 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
- K110599 — AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
- K110773 — TORNIER INSITE FT SUTURE ANCHOR
- K102788 — TORNIER BIOFIBER SCAFFOLD
- K110865 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K103262 — QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
- K102924 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K103007 — AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
- K100562 — LATITUDE ELBOW PROSTHESIS
- K093799 — TORNIER SURGICAL MESH
- K090139 — ANKLE ARTHRODESIS PLATE SYSTEM
- K090582 — CALCANEAL FRACTURE PLATE SYSTEM
- K083268 — TORNIER, INC., INSITE SUTURE ANCHORS
- K081707 — AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
- K080335 — TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
- K994041 — TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.