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Tornier SAS

Active in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000011808

Part of Tornier, Inc.

Devices
44
Registrations
EUDAMED
FDA recalls
2010 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA recalls

Catalogue44

Newest first, rows 1-44 of 44

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Rows 1-44 of 44

Company details

EUDAMED SRN
FR-MF-000011808
EU VAT number
FR90070501275
EUDAMED status
Active
EUDAMED registered name
Tornier SAS
Registered address
161, Rue Lavoisier, 38330, Montbonnot-Saint-Martin, France
Phone
+33 (0) 4 76 61 35 00
PRRC contact
Danielle Stap(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 1 Oct 2030

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 005434 0046 Active Supplemented

    Quality management system EU MDR

    Issued
    5 Aug 2026
    Expires
    1 Oct 2030
    Reason
    Add device or group

FDA recalls20

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

Recalls initiated per year

  • 2017 0
  • 2018 2
  • 2019 1
  • 2020 0
  • 2021 1
  • 2022 1
  • 2023 3
  • 2024 3
  • 2025 2
  • 2026 1

6 initiated before 2017

Showing the 10 most recent of 20 recalls.

  • 2026

    • 5 Mar 2026 Z-1769-2026 Class II Ongoing Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ,…
      Full distribution text US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI.
      Submission number: K251686

  • 2025

    • 19 Dec 2025 Z-1237-2026 Class II Ongoing 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 issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery. Distribution: US Nationwide distribution. Submission number: K161742
    • 3 Mar 2025 Z-1651-2025 Class II Ongoing A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct) Distribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany Submission number: K100562

  • 2024

    • 29 Aug 2024 Z-3155-2024 Class II Ongoing One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). Distribution: US Nationwide distribution in the states of IL, WI, AZ, NV, SD. Submission number: K220418
    • 29 Aug 2024 Z-3309-2024 Class II Ongoing 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 seating in the stem or spacer. Distribution: US Nationwide distribution. Submission number: K201315
    • 3 Jan 2024 Z-0773-2024 Class II Ongoing The incorrect device is contained in the labeled package. Distribution: Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign…
      Full distribution text Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.
      Submission number: K183696

  • 2023

    • 15 Sep 2023 Z-0113-2024 Class II Ongoing One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. Distribution: US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN Submission number: K161742
    • 12 Jun 2023 Z-2019-2023 Class II Ongoing 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 was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. Submission number: K191318
    • 12 Jun 2023 Z-2020-2023 Class II Ongoing 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 was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. Submission number: K191318

  • 2022

    • 3 May 2022 Z-1216-2022 Class II Ongoing The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. Distribution: US Nationwide distribution. Submission number: K161742
Show all 20 recalls

  • 2021

    • 28 May 2021 Z-2025-2021 Class II Terminated Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. Distribution: IL and TX Belgium, France and United Kingdom Submission number: K122698

  • 2019

    • 18 Oct 2019 Z-0405-2020 Class II Terminated During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem. Distribution: US Nationwide distribution. Submission number: K122698

  • 2018

    • 26 Mar 2018 Z-1757-2018 Class II Terminated Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. Distribution: US Nationwide Distribution Submission number: K082754
    • 8 Feb 2018 Z-1374-2018 Class II Terminated Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected. Distribution: US Nationwide Distribution. Submission number: K130422

  • 2016

    • 19 Sep 2016 Z-0699-2017 Class II Terminated Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. Distribution: US Distribution TX, CA, and MI Submission numbers: K141345, K152966

  • 2015

    • 6 Aug 2015 Z-2465-2015 Class II Terminated Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide. Distribution: Distributed to CA, ME, NC, PA, and TX. Submission number: K130533
    • 25 Jun 2015 Z-2315-2015 Class II Terminated Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws. Distribution: US: AL, AK, AZ, CA, CO, CT, FL, IL, IN, ME, MD, MI, MO, NC, OH, PA, TX. OUS: CANADA AND FRANCE. Submission number: K082754

  • 2013

    • 13 Aug 2013 Z-2199-2013 Class II Terminated Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R Distribution: .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN,…
      Full distribution text .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM

  • 2011

    • 23 Jun 2011 Z-3082-2011 Unclassified (pre-2012) Terminated Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. Distribution: Nationwide Distribution including FL and MO Submission number: K100562

  • 2009

    • 6 Apr 2009 Z-0455-2010 Unclassified (pre-2012) Terminated Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts). Distribution: Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France. Submission number: K023531

Frequently asked questions

How many devices does Tornier SAS have in the registry?

The registry currently lists 44 devices for Tornier SAS. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tornier SAS's devices?

Among its 44 most recently registered devices, Tornier SAS has devices listed in EUDAMED (44 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Tornier SAS's devices fall under?

Among its 44 most recently registered devices, the classes recorded for Tornier SAS's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for Tornier SAS?

FDA recall records list 20 recalls initiated by Tornier SAS, the most recent initiated on 5 Mar 2026. 10 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 EUDAMED certificates are recorded for Tornier SAS?

EUDAMED lists 1 certificate for Tornier SAS (quality management system) under MDR. The most recent was issued on 5 Aug 2026.

What are the newest devices from Tornier SAS in the registry?

The most recently registered devices listed for Tornier SAS include Tornier Pyrocarbon, RCPI, 611 - ANKLE FUSION NAIL and Pyrocardan.

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