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Tornier S.A.S.

Country not established FDA

Devices
20
Registrations
FDA
FDA recalls
1313 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

Catalogue20

Newest first, rows 1-20 of 20

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FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 2
  • 2025 10
  • 2026 0

Showing the 10 most recent of 13 recalls.

  • 2025

    • 10 Apr 2025 Z-1738-2025 Class II Ongoing A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.via FDA establishment Tornier S.A.S. Distribution: Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide. Submission number: K211359
    • 5 Mar 2025 Z-1534-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1535-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1536-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1537-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1538-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1539-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1540-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1541-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
    • 5 Mar 2025 Z-1542-2025 Class II Ongoing Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.via FDA establishment Tornier S.A.S. Distribution: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland Submission number: K222510
Show all 13 recalls

  • 2024

    • 18 Dec 2024 Z-0846-2025 Class II Ongoing The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.via FDA establishment Tornier S.A.S. Distribution: US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada Submission number: K222510
    • 16 Apr 2024 Z-1883-2024 Class II Ongoing The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.via FDA establishment Tornier S.A.S. Distribution: US Nationwide distribution in the states of FL, KY, NJ, and WI. Submission number: K211359

  • 2021

    • 25 Jun 2021 Z-2291-2021 Class II Ongoing Potential patient exposure to the graphite substrate.via FDA establishment Tornier S.A.S. Distribution: CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Tornier S.A.S. Montbonnot Saint-Martin Isere · FR FEI 3000931034

Frequently asked questions

How many devices does Tornier S.A.S. have in the registry?

The registry currently lists 20 devices for Tornier S.A.S.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tornier S.A.S.'s devices?

Among its 20 most recently registered devices, Tornier S.A.S. has devices listed in FDA 510(k) (20 devices).

What risk classes do Tornier S.A.S.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Tornier S.A.S.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Tornier S.A.S.?

FDA recall records list 13 recalls initiated by Tornier S.A.S., the most recent initiated on 10 Apr 2025. 13 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Tornier S.A.S. in the registry?

The most recently registered devices listed for Tornier S.A.S. include BLUEPRINT Patient Specific Instrumentation, AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM, 611 ANKLE FUSION NAIL and AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS.

Which FDA establishments are linked to Tornier S.A.S.?

1 FDA establishment is linked to Tornier S.A.S. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.