Tornier S.A.S.
Complete recall history across all FDA and CPSC categories — 13 total recalls
Tornier S.A.S. 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 (13)
FDA medical device enforcement actions by Tornier S.A.S.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 10, 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... | A software bug in Blueprint version 4.2.1 prevents users from accessing cases... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... | Stryker identified an elevated complaint rate related to difficulties using t... | Class II |
| Dec 18, 2024 | Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Ind... | The Pin Guide is being recalled because the metal tube may disassemble from t... | Class II |
| Apr 16, 2024 | Stryker Blueprint Software, Catalog #BPUE001. | The software bug allows for case planning with anatomic glenoid Perform / Per... | Class II |
| Jun 25, 2021 | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS... | Potential patient exposure to the graphite substrate. | 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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