Chrysalis Intelligence · Sponsors · Tornier, Inc.

Tornier, Inc.

Bloomington, MN, US · 10 510(k) clearances · 11 recalls

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Total clearances
10
2020-08-05 → 2026-07-22
Last 12 months
3
Product codes
7
Most recent
2026-07-22
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 4 2026-01-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class II Orthopedic 1 2026-07-22
KWT — — — 1 2025-10-30
HSB Rod, Fixation, Intramedullary And Accessories Class II Orthopedic 1 2023-10-31
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Class II Orthopedic 1 2022-09-14
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class II Orthopedic 1 2020-09-11
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Class II Orthopedic 1 2020-08-05
Safety

Recalls (11)

Class I (serious)
0
Risk of injury / death
Total recalls
11
Currently ongoing
10
Most recent
2026-03-05
DateSeverityStatusRecall # ProductCodeReason
2026-03-05 Class II Ongoing Z-1769-2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max … — Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with t…
2025-12-19 Class II Ongoing Z-1237-2026 TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 — A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the…
2025-03-03 Class II Ongoing Z-1651-2025 stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Se… — A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow c…
2024-08-29 Class II Ongoing Z-3309-2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty — Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely…
2024-08-29 Class II Ongoing Z-3155-2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the s… — One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
2024-01-03 Class II Ongoing Z-0773-2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. — The incorrect device is contained in the labeled package.
2023-09-15 Class II Ongoing Z-0113-2024 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 — One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance pr…
2023-06-12 Class II Ongoing Z-2020-2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 — A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it w…
2023-06-12 Class II Ongoing Z-2019-2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 — A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it w…
2022-05-03 Class II Ongoing Z-1216-2022 Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit — The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
2021-05-28 Class II Terminated Z-2025-2021 Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier … — Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Filings

All 510(k) clearances (10)

Date K-number Device Code Class Specialty
2026-07-22 K260721 Tornier Perform Advanced Glenoid KWS Class II Orthopedic
2026-01-08 K252788 Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) PHX Class II Orthopedic
2025-10-30 K251686 Tornier Humeral Reconstruction System Max (Tornier HRS Max) KWT — —
2023-10-31 K230352 Tornier Humeral Nail and Tornier Long Humeral Nail HSB Class II Orthopedic
2022-10-14 K220914 Tornier Perform Humeral System – Fracture PHX Class II Orthopedic
2022-09-14 K220418 Tornier Perform Humeral System – Stemless PKC Class II Orthopedic
2021-11-12 K211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation PHX Class II Orthopedic
2021-10-26 K213124 Tomier Perform™ Reversed Glenoid Cannulated Glenospheres PHX Class II Orthopedic
2020-09-11 K201315 PERFORM Humeral System – Stem PAO Class II Orthopedic
2020-08-05 K193247 LATITUDE EV™ Total Elbow Arthroplasty JDB Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence