I.T.S. GmbH
Complete recall history across all FDA and CPSC categories — 18 total recalls
I.T.S. GmbH appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (18)
FDA medical device enforcement actions by I.T.S. GmbH
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 23, 2026 | Pelvic Reconstruction System (PRS) with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Volar Radius Plate with Angular Stability with the following description: Rad... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Pilonplate with Angular Stability, with the below descriptions and correspond... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | FR.O.H. Calcaneus Repair System with the following description: Anterolateral... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) Syst... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Brand Name: Humeral Head Plate with Angular Stability, with the following des... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Claviculaplate with Angular Stability, with the below descriptions and associ... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | I.T.S. Fibula Plate PROlock with Angular Stability with the below description... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | I.T.S. LRS (Locking Reconstruction System) with the below descriptions and co... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with t... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | I.T.S. Straight Plate with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Distal Humeral Plates with Angular Stability with the below descriptions and ... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | HLS - Hand Locking Plates System with the below descriptions and correspondin... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | I.T.S. Screw System with the below descriptions and corresponding article num... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | Olecranonplate with Angular Stability with the below descriptions and corresp... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate wit... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| Jan 23, 2026 | HCS - Headless Compression Screw System, Headless Compression Screw, Cannulat... | Updated MRI safety testing demonstrates higher RF-induced temperature increas... | Class II |
| May 9, 2019 | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usa... | The titanium implant has the wrong article number laser marked on it. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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