PlainRecalls

I.t.s. GmbH

18 recalls on record · Latest: Apr 1, 2026

I.t.s. GmbH Recall Insight

I.t.s. GmbH appears on 18 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.021% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 1, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 18 entries, severity tagging shows 0 critical, 18 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 18 of 18 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (18). The date window on this page runs from Jun 12, 2019 to Apr 1, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 1, 2026

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 3…

FDA Devices Moderate Apr 1, 2026

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS -…

FDA Devices Moderate Apr 1, 2026

Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 211…

FDA Devices Moderate Apr 1, 2026

I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31…

FDA Devices Moderate Apr 1, 2026

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 3215…

FDA Devices Moderate Apr 1, 2026

Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article N…

FDA Devices Moderate Apr 1, 2026

I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Num…

FDA Devices Moderate Apr 1, 2026

Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Co…

FDA Devices Moderate Apr 1, 2026

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Fe…

FDA Devices Moderate Apr 1, 2026

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Articl…

FDA Devices Moderate Apr 1, 2026

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Nu…

FDA Devices Moderate Apr 1, 2026

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, …

FDA Devices Moderate Apr 1, 2026

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.…

FDA Devices Moderate Apr 1, 2026

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

FDA Devices Moderate Apr 1, 2026

Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: …

FDA Devices Moderate Apr 1, 2026

Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032…

FDA Devices Moderate Apr 1, 2026

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2…

FDA Devices Moderate Jun 12, 2019

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolid…

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Data Sources

  • Source: FDA + CPSC + NHTSA — federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all three federal recall feeds