Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1593-2026 — 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 Numbers: 21122-10,

U.S. FDA — Device Enforcement · Austria · 2026-01-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1593-2026
Date of alert: 2026-01-23
Country / jurisdiction: Austria
Risk level: Class II
Risk type: recall
Brand: I.T.S. GmbH
Product category: device
Product type: Devices

Reported risk: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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