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Tornier S.A.S. FDA Inspection Record

FEI 3000931034 · Inspections, Form 483s, warning letters and import refusals

Tornier S.A.S. is an FDA-registered facility (FEI 3000931034) located in Montbonnot Saint-Martin Isere, FR. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Apr 4, 2013: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
5, latest Apr 10, 2025
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 4, 2013Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 10, 2025Class IIZ-1738-2025Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for…
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Mar 5, 2025Class IIZ-1534-2025stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog… and 8 more products
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is…
Dec 18, 2024Class IIZ-0846-2025Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for…
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed…
Apr 16, 2024Class IIZ-1883-2024Stryker Blueprint Software, Catalog #BPUE001.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex…
Jun 25, 2021Class IIZ-2291-2021The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a)…
Potential patient exposure to the graphite substrate.

FDA record score

15 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1738-2025, this FEI as the recalling firmApr 10, 20254 x 14
Class II recall Z-1534-2025, this FEI as the recalling firmMar 5, 20254 x 14
Class II recall Z-0846-2025, this FEI as the recalling firmDec 18, 20244 x 14
Class II recall Z-1883-2024, this FEI as the recalling firmApr 16, 20244 x 0.62.4
Class II recall Z-2291-2021, this FEI as the recalling firmJun 25, 20214 x 0.251
Inspection classified VAIApr 4, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Tornier S.A.S.
Location
Montbonnot Saint-Martin Isere (FR)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.