Reported Apr 1, 2026 · Ongoing
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle…
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?
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 21116-8, 21117-10, 21118-10. 2. Clavicle Plate |
| 2 | Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm |
| 3 | Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral |
| 4 | Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6. |
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
21116-8 (679/092230)21117-10 (679/032313679/092231)21118-10 (679/032314679/072047679/092232). 2
- Article Number (Lot Numbers)
21121-6 (679/092236679/092329)21121-8 (679/052226). 3
- Article Number (Lot Numbers)
21122-10 (00/0425-0200/0825-02679/022443679/06231086/043372)21122-6 (00/0325-0100/0425-01679/042340679/062334679/12226986/043366)21122-8 (00/0325-08679/022243679/022304679/022451679/042209679/042214679/052319679/10236886/043368). 4
- Article Number (Lot Numbers)
21123-4 (00/0810-06679/052014679/062216)21124-4 (679/042333679/062217679/072346)21127-6 (679/052228)21128-6 (679/042341)
- Amount recalled
- 322 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.
Free recall alerts
Get alerted about new I.T.S. GmbH recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.