Tornier, Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Tornier, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by Tornier, Inc

Date Product Reason Class
Mar 5, 2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... Affected products were incorrectly labeled as Tornier HRS Max products. These... Class II
Dec 19, 2025 TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx... Class II
Mar 3, 2025 stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side... A specific lot of Latitude Humeral Trial Stems has the incorrect direct part ... Class II
Aug 29, 2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, f... Devices from one lot of Perform" Reversed Inserts may contain a locking ring ... Class II
Aug 29, 2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DW... One lot of Perform Humeral Nucleus may exceed the specification for bacterial... Class II
Jan 3, 2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... The incorrect device is contained in the labeled package. Class II
Sep 15, 2023 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... One lot of Tournier Perform Reversed Lateralized Baseplates were found to hav... Class II
Jun 12, 2023 AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 A comingle/swap resulted in the labeling and laser marking on the product to ... Class II
Jun 12, 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 ... Class II
May 3, 2022 Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit The device is unable to meet sterilization requirements when sterilized per i... Class II
May 28, 2021 Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray compone... Two lots have been swapped thus have the incorrect product in the package. Th... Class II
Oct 18, 2019 Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 D... During shipping, it is possible for the Aequalis Ascend Flex humeral stem to ... Class II
Mar 26, 2018 AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... Drill bit tips without new BargerGard tip protector may puncture through ster... Class II
Feb 8, 2018 Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM... Data has shown that degradation of a raw material used in Phantom Fiber may o... Class II
Sep 19, 2016 Aequalis Fx2 implant parts and instrument trays. Insert component : Part ... Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument... Class II
Aug 6, 2015 Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile... Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (... Class II
Jun 25, 2015 Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic man... Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due... Class II
Aug 13, 2013 AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products ... Following the identification of the disassociation of an impactor tip during ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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