Facility

Z-SYSTEMS AG

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

Key facts

1recalls · worst Class II

1inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3006948427
Establishment type	Manufacture Medical Device
Location	Werkhofstrasse 5 Oensingen Solothurn, CH 4702
Registration status	Active · expires 2026
Parent company	Z-SYSTEMS AG (owner-operator 10024995)
Brand names	Z5m(t); Z5m(t)-neo

Activity by year

Recalls (1)
Inspections (1)
Warning letters (1)

Devices registered here (1)

Implant, Endosseous, Root-Form
Product code DZE (opens in a new tab) · Class II · Dental · 21 CFR 872.3640

Recalls & enforcement

Class IITerminated2013-05-16
Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

FDA inspections (1)

OAI2024-04-25
Official Action Indicated · Compliance: Devices · citations posted

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.

FDA warning letters (1)

Warning Letter2024-08-02
Warning Letter (opens in a new tab) · Oensingen

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Z-SYSTEMS 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. “Z-SYSTEMS AG (FEI 3006948427) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006948427-z-systems-ag/

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