The Recall Desk

Manufacturer

Tornier, Inc

18 recalls in our database name Tornier, Inc as the manufacturing or recalling firm.

What the numbers show

Total
18
Critical
0
Severe
1
Most recent
2026-04-15

Of the 18 recalls from Tornier, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–18 of 18

  • HighFDA (Devices)·Z-1769-2026·2026-04-15

    Tornier shoulder system parts mislabeled as compatible with the HRS Max

    Tornier HRS Max tuberosity bodies and a trial component were incorrectly labeled as HRS Max products; they are compatible only with the Tornier HRS system. 233 units are affected.

    Product
    Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2026·2026-02-11

    Peripheral screws recalled after a lot was labeled the wrong length

    Tornier is recalling 427 Perform Reversed peripheral screws because a lot labeled 5.0mm x 18mm actually contains 5.00mm x 14mm screws.

    Product
    TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2025·2025-04-30

    Stryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking

    A specific lot of Stryker Latitude Humeral Trial Stems has incorrect laser marking and color indicator, potentially resulting in implantation of the wrong device size and orientation.

    Product
    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3309-2024·2024-10-09

    Stryker Tornier Shoulder Implant Insert May Not Seat Securely

    Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.

    Product
    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3155-2024·2024-09-25

    Shoulder implant recalled due to excessive bacterial endotoxin

    Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.

    Product
    stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2024·2024-01-31

    Stryker Tornier Shoulder Implant Recalled for Device Packaging Mismatch

    Tornier, Inc is recalling 50 units of Stryker Tornier Perform shoulder implants because the incorrect device is contained in the labeled package. Affected batch: lot 6714AZ, serial 001–050.

    Product
    Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0113-2024·2023-10-25

    Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect

    One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.

    Product
    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2020-2023·2023-07-05

    Orthopedic assembly screws with incorrect model number labeling and markings

    AEQUALIS FLEX REVIVE assembly screws were mislabeled during manufacturing, with some units marked as 0mm Standard actually being 0mm Short and vice versa. Surgeons must verify model numbers before use.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2023·2023-07-05

    Orthopedic Assembly Screws Recalled Due to Labeling and Size Swap Error

    Tornier recalled 55 AEQUALIS FLEX REVIVE Assembly Screws (Model ARS655101) due to a labeling swap where Standard-length units were marked Short, and vice versa. This could result in implantation of the wrong screw size during orthopedic surgery.

    Product
    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2022·2022-06-08

    Ratcheting Screwdriver Handle in Surgical Kit Unable to Meet Sterilization Requirements

    Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.

    Product
    Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2021·2021-07-21

    Shoulder prosthesis component distributed with incorrect thickness due to lot swap

    Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.

    Product
    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0405-2020·2019-11-20

    Tornier Recalls Aequalis Ascend Flex Humeral Stems Due to Packaging Material Transfer

    Tornier, Inc. is recalling 87,869 Aequalis Ascend Flex Humeral Stems because movement during shipping may cause PETG material from the packaging to transfer to the device.

    Product
    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 370038694456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1757-2018·2018-05-16

    Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

    Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

    Product
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2018·2018-04-25

    Tornier Recalls Phantom Fiber Sutures Due to Potential Strength Loss

    Tornier, Inc. is recalling 32,253 units of Phantom Fiber sutures because improper storage may cause the raw material to degrade, leading to a loss of suture strength.

    Product
    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DW
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2465-2015·2015-09-02

    Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect

    Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.

    Product
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2315-2015·2015-08-05

    Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation

    Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.

    Product
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2199-2013·2013-09-25

    Tornier Recalls Aequalis Reversed II and Fracture Impactors

    Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.

    Product
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.
    Category
    Medical Device
    Distribution
    21 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

TORNIER

Source: Wikidata (Q140203181), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.