Reported Apr 1, 2026 · Ongoing
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm…
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?
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 21604-6, 21604-9. 2. Forearm Plate, Straight |
| 2 | Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate |
| 3 | Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm |
| 4 | Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm |
| 5 | Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm |
| 6 | Article Number: 21102-6. 7. Straight Plate, 4.5mm |
| 7 | Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9. |
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21604-6 (643/052301643/0652643/092201)21604-9 (643/032311643/062308643/062309643/112310643/122201). 2
- Article Number (Lot Numbers)
21605-11 (643/072314643/102207)21605-6 (643/0654643/072306643/072316643/072338643/102208643/102212643/102217643/112306643/122202)21605-9 (643/0643643/0662643/072307643/072339643/112309643/122203). 3
- Article Number (Lot Numbers)
21105-6 (86/876787)21105-8 (86/876788). 4
- Article Number (Lot Numbers)
21104-4 (679/052234679/08230586/036334)21104-5 (679/0722101679/08230686/036335)21104-6 (679/01230786/876760)21104-7 (679/08230786/03633686/876781)21104-8 (679/08230886/876783)21104-9 (86/876904). 5
- Article Number (Lot Numbers)
21101-5 (86/876637)21101-6 (679/12160500/1105-1226/F4192386/87663886/903610)21101-7 (770/20190500/0518-06679/04230386/876640)21101-8 (86/876721679/062224)21101-9 (679/12226486/876727)21101-11 (86/876633)21101-13 (86/876635). 6
- Article Number (Lot Numbers)21102-6 (770/201905). 7
- Article Number (Lot Numbers)
21103-8 (679/092216)21103-9 (679/06221586/876758)21103-10 (679/09221986/876741)21103-11 (679/062214)21103-12 (86/876743)21103-13 (679/02230386/876745)
- Amount recalled
- 510 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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