Facility

PARAGON 28

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

Key facts

10recalls · worst Class II

2inspections · worst OAI

—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)	3008650117
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	14445 Grasslands Dr. Englewood, CO, US 80112
Registration status	Active · expires 2026
Parent company	Paragon 28 (owner-operator 10033376)
Brand names	Additive Orthopaedics Bunion System

Activity by year

Recalls (10)
Inspections (2)

Devices registered here (2)

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

Recalls & enforcement

Class IIIOngoing2026-07-10
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Class IIOngoing2026-06-17
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Class IIOngoing2025-10-13
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentat…
Class IIOngoing2023-12-21
Medical devices distributed, prior to sterilization
Class IIOngoing2022-07-13
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Class IIOngoing2022-05-26
Due to Titanium plasma coating not present implant.
Class IIOngoing2022-05-18
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Class IITerminated2021-07-30
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Class IITerminated2018-09-28
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Class IITerminated2017-12-19
Missing drill guide as stated in the package.

FDA inspections (2)

OAI2025-04-24
Official Action Indicated · Project Evaluation: Devices · citations posted
NAI2023-07-13
No Action Indicated · Radiation Control and Health Safety Act

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 Paragon 28

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. “PARAGON 28 (FEI 3008650117) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008650117-paragon-28/

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