Facility

Cerapedics, Inc.

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

Key facts

2recalls · worst Class II

3inspections · worst VAI

—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)	3007155473
Establishment type	Manufacture Device in the United States for Export Only
Location	11025 Dover Street Westminster, CO, US 80021
Registration status	Active · expires 2026
Parent company	Cerapedics, Inc. (owner-operator 10026681)
Brand names	i-FACTOR Flex FR; P-15 Bone Putty; i-FACTOR Bone Graft-Putty; i-FACTOR Putty; i-FACTOR Flex; i-FACTOR Bone Graft-Flex

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (1)

Filler, Bone Void, Non-Osteoinduction
Product code MBS (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-12-29
Incorrect expiration date
Class IIITerminated2022-04-14
Patient chart label contains incorrect Part Number and volume amount.

FDA inspections (3)

VAI2024-03-13
Voluntary Action Indicated · Postmarket Assurance: Devices
NAI2019-10-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-12-09
Voluntary Action Indicated · Compliance: Devices; Project Evaluation: 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.

All facilities operated by Cerapedics, 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. “Cerapedics, Inc. (FEI 3007155473) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007155473-cerapedics-inc/

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