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I.T.S Recalls

18 recalls on record · June 12, 2019 to April 1, 2026 · Medical Devices

Recalls by year

19
26

Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and correspo
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1.
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw;
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated;
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
April 1, 2026Medical DevicesFDA
I.T.S. GmbH recalls Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103
Hazard: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
June 12, 2019Medical DevicesFDA
I.T.S. GmbH recalls Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone
Hazard: The titanium implant has the wrong article number laser marked on it.
I.T.S Recalls | RecallWatchUSA