Facility

THOMMEN MEDICAL, AG

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

Key facts

2recalls · 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)	3003184527
Establishment type	Manufacture Medical Device
Location	NECKARSULMSTRASSE 28 GRENCHEN Solothurn, CH CH-2540
Registration status	Active · expires 2026
Parent company	THOMMEN MEDICAL, AG (owner-operator 9051144)
Brand names	SPI ART Abutments

Activity by year

Recalls (2)

Devices registered here (1)

Abutment, Implant, Dental, Endosseous
Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630

Recalls & enforcement

Class IIOngoing2024-01-24
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Class IITerminated2019-04-03
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).

All facilities operated by THOMMEN MEDICAL, AG

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. “THOMMEN MEDICAL, AG (FEI 3003184527) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003184527-thommen-medical-ag/

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