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Paragon 28

Active in EUDAMED

Registered as Paragon 28 Inc. (Paragon 28 Inc.) in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000030676 FEI 3008650117

Devices
10,538
Registrations
EUDAMEDFDA
FDA recalls
1310 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Paragon 28 makes

Paragon 28 manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws and plates for bone stabilization, as well as fixed-bearing total ankle prostheses for joint replacement. The company also produces reusable surgical implant templates, arthrodesis intramedullary nails, and external fixation systems for fracture management. Sterilization containers for reusable devices are part of the portfolio, alongside minimally invasive bunion correction systems.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10,538

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000030676
FDA FEI number
3008650117
EUDAMED status
Active
EUDAMED registered name
Paragon 28 Inc.
EUDAMED abbreviated name
Paragon 28 Inc.
Registered address
14445, Grasslands Drive, 80112, Englewood, Colorado, United States
Phone
+1 888 728 1888
PRRC contact
Tina O'Brien(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 7 Jul 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 727623 Expiring Supplemented Expires in 238 days

    Quality management system EU MDR

    Issued
    24 Apr 2025
    Expires
    7 Jul 2027
    Reason
    Add device or group

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by Paragon 28, the earliest on 2017-12-19 and the most recent on 2026-07-10. By recorded status: 10 ongoing and 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 3
  • 2023 3
  • 2024 0
  • 2025 1
  • 2026 3

Showing the 10 most recent of 13 recalls.

  • 2026

    • 10 Jul 2026 Z-2971-2026 Class III Ongoing Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. Distribution: US Nationwide distribution i the state of MT.
    • 10 Jul 2026 Z-2972-2026 Class III Ongoing Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. Distribution: US Nationwide distribution i the state of MT.
    • 17 Jun 2026 Z-2758-2026 Class II Ongoing Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand

  • 2025

    • 13 Oct 2025 Z-0871-2026 Class II Ongoing 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 instrumentation, the surgery potentially will need to be aborted. Distribution: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. Submission number: K234128

  • 2023

    • 21 Dec 2023 Z-1254-2024 Class II Ongoing Medical devices distributed, prior to sterilization Distribution: US:CA OUS: None Submission number: K210869
    • 21 Dec 2023 Z-1255-2024 Class II Ongoing Medical devices distributed, prior to sterilization Distribution: US:CA OUS: None Submission number: K210869
    • 21 Dec 2023 Z-1256-2024 Class II Ongoing Medical devices distributed, prior to sterilization Distribution: US:CA OUS: None Submission number: K210869

  • 2022

    • 13 Jul 2022 Z-1776-2022 Class II Ongoing Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. Distribution: US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA. Submission number: K211002
    • 26 May 2022 Z-1468-2022 Class II Ongoing Due to Titanium plasma coating not present implant. Distribution: U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY. Submission number: K171715
    • 18 May 2022 Z-1458-2022 Class II Ongoing Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. Distribution: International distribution in the country of UK.
Show all 13 recalls

  • 2021

    • 30 Jul 2021 Z-2488-2021 Class II Terminated 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. Distribution: U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A

  • 2018

    • 28 Sep 2018 Z-0662-2020 Class II Terminated 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. Distribution: AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX,…
      Full distribution text AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY OUS: Australia & Israel
      Submission number: K162241

  • 2017

    • 19 Dec 2017 Z-2261-2018 Class II Terminated Missing drill guide as stated in the package. Distribution: Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI,…
      Full distribution text Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
      Submission number: K170923

Frequently asked questions

How many devices does Paragon 28 have in the registry?

The registry currently lists 10538 devices for Paragon 28. Devices recorded under merged duplicate company entries are counted once.

Which registries list Paragon 28's devices?

Among its 50 most recently registered devices, Paragon 28 has devices listed in EUDAMED (50 devices).

What risk classes do Paragon 28's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Paragon 28's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.

Are there FDA recall records for Paragon 28?

FDA recall records list 13 recalls initiated by Paragon 28, the most recent initiated on 10 Jul 2026. 10 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Paragon 28?

EUDAMED lists 1 certificate for Paragon 28 (quality management system) under MDR. The most recent was issued on 24 Apr 2025.

What are the newest devices from Paragon 28 in the registry?

The most recently registered devices listed for Paragon 28 include Baby Gorilla / Gorilla Plating System, Monster Screw System, Monster® Screw System and Baby Gorilla®/Gorilla® Plating System.

Generated automatically from registry data and not verified by a human reviewer.