Facility

KELYNIAM GLOBAL INC.

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

Key facts

1recalls · worst Class II

5inspections · 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)	3009424796
Establishment type	Manufacture Medical Device
Location	97 RIVER RD STE A COLLINSVILLE, CT, US 06019
Registration status	Active · expires 2026
Parent company	Kelyniam Global Inc. (owner-operator 10054881)
Brand names	Customized Craniofacial Implant (CCI)

Activity by year

Recalls (1)
Inspections (5)
Warning letters (1)

Devices registered here (1)

Plate, Cranioplasty, Preformed, Non-Alterable
Product code GXN (opens in a new tab) · Class II · Neurology · 21 CFR 882.5330

Recalls & enforcement

Class IITerminated2017-06-10
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal S…

FDA inspections (5)

VAI2024-08-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-07-22
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2019-08-15
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2018-09-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-05-30
Official Action Indicated · Compliance: Devices; Postmarket Assurance: 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 Letter2017-10-05
Warning Letter (opens in a new tab) · Collinsville Connecticut

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 Kelyniam Global Inc.

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. “KELYNIAM GLOBAL INC. (FEI 3009424796) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009424796-kelyniam-global-inc/

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