Reported Apr 1, 2026 · Ongoing
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral…
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?
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm |
| 2 | Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small |
| 3 | Article Numbers: 21093-4, 21093-6. |
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21311-11 (26/F62573)21311-15 (26/F6504826/F67521)21311-7 (26/F6616526/F67825)21312-11 (26/F6504926/F67826)21312-15 (26/F66166)21312-7 (26/F6564326/F67827). 2
- Article Number (Lot Numbers)
21094-10 (643/032304643/082309)21094-4 (643/0572643/0571)21094-6 (643/112202)21094-8 (643/012309). 3
- Article Number (Lot Numbers)
21093-4 (679/032311679/112331)21093-6 (679/112332)
- Amount recalled
- 101 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.
Want the full recall guide?
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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