Reported Apr 1, 2026 · Ongoing
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
I.T.S. GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A
Is this the product you have?
- FR.O.H. Calcaneus Repair
- System with the following descriptionAnterolateral Calcaneus Plate
- Article Number21064-60
- Lot codes and dates
- Article Number (Lot Numbers)
21064-60 (679/012318679/0722100)
- Article Number (Lot Numbers)
- Amount recalled
- 4 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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