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,
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 23, 2026 |
| Reported | April 01, 2026 |
| Recalling firm | I.T.S. GmbH |
| Country / region | Austria US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. |
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Product description
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, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Affected products
- Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 2111
Related recalls
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