The Recall Desk

Manufacturer

I.T.S. GmbH

17 recalls in our database name I.T.S. GmbH as the manufacturing or recalling firm.

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.

1–17 of 17

  • HighFDA (Devices)·Z-1598-2026·2026-04-01

    I.T.S. straight and forearm plates heat more in MRI than stated

    I.T.S. GmbH is recalling Straight Plates with Angular Stability, including forearm and compression plates, because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Pla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2026·2026-04-01

    I.T.S. olecranon plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling Olecranon Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2026·2026-04-01

    I.T.S. hand locking plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling the HLS Hand Locking Plates System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2026·2026-04-01

    I.T.S. distal ulna plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling the Distal Ulna Locking and Ulna Osteotomy Locking Systems because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2026·2026-04-01

    I.T.S. foot locking plates heat more in MRI than stated

    I.T.S. GmbH is recalling the FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2026·2026-04-01

    I.T.S. pilon and tibia plates heat more in MRI than stated

    I.T.S. GmbH is recalling Pilon Plates with Angular Stability and Anterolateral Tibia Plates because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 2109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2026·2026-04-01

    I.T.S. pelvic reconstruction screws heat more in MRI than stated

    I.T.S. GmbH is recalling the Pelvic Reconstruction System fixation screw and short spike because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2026·2026-04-01

    I.T.S. fibula and tubular plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Fibula Plate PROlock with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2026·2026-04-01

    I.T.S. calcaneus repair plate heats more in MRI than stated

    I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System anterolateral calcaneus plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2026·2026-04-01

    I.T.S. distal humeral plates heat more in MRI than stated

    I.T.S. GmbH is recalling Distal Humeral Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2026·2026-04-01

    I.T.S. proximal humeral plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Humeral Head Plate with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2026·2026-04-01

    I.T.S. clavicle plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling Clavicula Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2026·2026-04-01

    I.T.S. femur and tibia plates heat more in MRI than stated

    I.T.S. GmbH is recalling the LRS Locking Reconstruction System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2026·2026-04-01

    I.T.S. pelvic reconstruction plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Pelvic Reconstruction System PRS RX and PRS Phoenix because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2026·2026-04-01

    I.T.S. cannulated screw system heats more in MRI than stated

    I.T.S. GmbH is recalling the I.T.S. Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2026·2026-04-01

    I.T.S. volar radius plates heat more in MRI than stated

    I.T.S. GmbH is recalling Volar Radius Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2026·2026-04-01

    I.T.S. headless compression screws heat more in MRI than stated

    I.T.S. GmbH is recalling the HCS Headless Compression Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31
    Category
    Medical Device
    Distribution
    Distributed nationwide