The Recall Desk

Manufacturer

Tornier S.A.S.

13 recalls in our database name Tornier S.A.S. as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2025-05-14

Of the 13 recalls from Tornier S.A.S. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–13 of 13

  • ModerateFDA (Devices)·Z-1738-2025·2025-05-14

    Blueprint Software version 4.2.1 surgical planner access bug

    Tornier's Blueprint Software version 4.2.1 contains a bug that prevents surgeons from accessing surgical cases created in earlier software versions.

    Product
    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2025·2025-04-16

    Stryker Blueprint Mixed Reality Instrument Check Block Recall

    Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.

    Product
    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1534-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall

    Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Glenoid Pin Guide due to elevated complaint rates regarding software and instrumentation functioning issues that prevent the product from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1542-2025·2025-04-16

    Stryker HoloBlueprint Application Medical Device Software Functionality Recall

    Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1538-2025·2025-04-16

    Stryker Blueprint Mixed Reality surgical guidance system Class II recall

    Stryker is recalling the Blueprint Mixed Reality Box Base used in Total Shoulder Arthroplasty due to elevated complaints of software and instrumentation malfunctions that prevent intended use.

    Product
    stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1536-2025·2025-04-16

    Stryker Blueprint Mixed Reality Coracoid Clamp Software and Instrumentation Issues

    Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to elevated complaints about impaired software and instrumentation functioning that prevent the system from meeting its intended use in shoulder surgery guidance.

    Product
    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1535-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Digitizer Software Functioning Issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer due to elevated complaint rates affecting system functionality. The device cannot reliably meet its intended use in total shoulder arthroplasty procedures.

    Product
    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1540-2025·2025-04-16

    Stryker Blueprint Mixed Reality Depth Stop Pin Total Shoulder Arthroplasty Recalled

    Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaints of software and instrumentation malfunctions that prevent intended use. The recall affects 474 units distributed in multiple US states and internationally.

    Product
    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1541-2025·2025-04-16

    Stryker Blueprint Mixed Reality Instrument Kit Recall for Total Shoulder Arthroplasty

    Stryker is recalling the Blueprint Mixed Reality Instrument Kit for Total Shoulder Arthroplasty due to an elevated rate of complaints about software and instrumentation malfunctions that prevent the system from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1539-2025·2025-04-16

    Stryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues

    Stryker is recalling the Blueprint Mixed Reality Glenoid Box Lid and related instrumentation kits due to elevated complaint rates. The product experiences software and instrumentation issues that prevent it from meeting its intended use.

    Product
    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0846-2025·2025-01-22

    Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery

    The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.

    Product
    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2291-2021·2021-08-25

    Tornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure

    Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.

    Product
    The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog
    Category
    Medical Device
    Distribution
    15 states