Facility

ICOTEC AG

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

Key facts

2recalls · 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)	3006493760
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Industriestrasse 12 Altstaetten Sankt Gallen, CH 9450
Registration status	Active · expires 2026
Parent company	icotec ag (owner-operator 10042564)

Activity by year

Recalls (2)

Devices registered here (2)

Spinal Vertebral Body Replacement Device - Cervical
Product code PLR (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060
Spinal Vertebral Body Replacement Device
Product code MQP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060

Recalls & enforcement

Class IIOngoing2023-11-28
icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was…
Class IITerminated2022-11-03
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.

All facilities operated by icotec 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. “ICOTEC AG (FEI 3006493760) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006493760-icotec-ag/

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