Drug & Device Safety Atlas

FDA recall record · openFDA

I.T.S. GmbH

17 FDA recalls on record (2026) — 17 device. 17 still ongoing.

0
Class I (most serious)
17
Class II
0
Class III
17
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previo 17

Recalls

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31 Class II 2026-01-23 FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding Class II 2026-01-23 Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hoo Class II 2026-01-23 I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Class II 2026-01-23 HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; A Class II 2026-01-23 Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Corti Class II 2026-01-23 I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forea Class II 2026-01-23 Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding art Class II 2026-01-23 I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di Class II 2026-01-23 I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Class II 2026-01-23 Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi Class II 2026-01-23 Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N Class II 2026-01-23 I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and correspo Class II 2026-01-23 FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. Class II 2026-01-23 Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral T Class II 2026-01-23 Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103 Class II 2026-01-23 Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Class II 2026-01-23

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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