Facility

DUFNER INSTRUMENTE GMBH

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3002806862
Establishment type	Manufacture Medical Device
Location	FOEHRENSTR. 9 TUTTLINGEN Baden-Wurttemberg, DE 78532
Registration status	Active · expires 2026
Parent company	DUFNER INSTRUMENTE GMBH (owner-operator 8010266)
Brand names	HAND DRILLS

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Bit, Drill
Product code HTW (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540

Recalls & enforcement

Class IITerminated2020-06-03
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury

FDA inspections (1)

NAI2024-03-13
No Action Indicated · Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by DUFNER INSTRUMENTE GMBH

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. “DUFNER INSTRUMENTE GMBH (FEI 3002806862) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806862-dufner-instrumente-gmbh/

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