Facility

SYNTHES 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)	3009417901
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Luzernstrasse 21 Zuchwil Solothurn, CH CH-4528
Registration status	Active · expires 2026
Parent company	SYNTHES GMBH / Synthes Produktions GmbH (owner-operator 9071542)
Brand names	Plate, fixation, bone; Screw, fixation, bone

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
Plate, Fixation, Bone
Product code HRS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

Class IITerminated2020-06-16
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

FDA inspections (1)

NAI2016-12-16
No Action Indicated · Compliance: 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.

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. “SYNTHES GMBH (FEI 3009417901) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009417901-synthes-gmbh/

Not open yet

Alerts for SYNTHES GMBH

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.