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)	3000270450
Establishment type	Manufacture Medical Device
Location	Industriestrasse 28 Selzach Solothurn, CH 2545 Selz.
Registration status	Active · expires 2026
Parent company	SYNTHES GMBH / Synthes Produktions GmbH (owner-operator 9071542)
Brand names	Expedium Spine System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (4)

Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Thoracolumbosacral Pedicle Screw System
Product code NKB (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Appliance, Fixation, Spinal Interlaminal
Product code KWP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3050
Orthosis, Spinal Pedicle Fixation
Product code MNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

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)

NAI2017-08-08
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 3000270450) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000270450-synthes-gmbh/

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