Facility

XION GmbH

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)	3003276727
Establishment type	Repack or Relabel Medical Device
Location	Pankstrasse 8 Berlin, DE 13127
Registration status	Active · expires 2026
Parent company	HENKE-SASS WOLF, GMBH. (owner-operator 8010418)
Brand names	Henke Sass Wolf of America Arthroscope; Xion arthroscopes

Activity by year

Recalls (1)

Devices registered here (1)

Arthroscope
Product code HRX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.1100

Recalls & enforcement

Class IIOngoing2023-07-27
Sterile barrier might be damaged compromising the sterility of the device.

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. “XION GmbH (FEI 3003276727) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003276727-xion-gmbh/

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