Facility

ORTOMA AB

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014411622
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	Falkenbergsgatan 3 Gothenburg Vastra Gotaland, SE 41285
Registration status	Active · expires 2026
Parent company	Ortoma AB (owner-operator 10091322)
Brand names	OTS Hip; OTS Hip Solution Pinnacle; OTS Hip Solution Emphasys

Activity by year

Recalls (1)

Devices registered here (1)

Orthopedic Stereotaxic Instrument
Product code OLO (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IIOngoing2025-07-28
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.

All facilities operated by Ortoma AB

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ORTOMA AB (FEI 3014411622) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014411622-ortoma-ab/

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