Ortoma AB
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (1)
- ORTOMA AB FEI 3014411622 · SE
Recalls & enforcement
- Class IIOngoing2025-07-28Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Ortoma AB — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10091322-ortoma-ab/
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