Englewood, CO, United States
Paragon 28, Inc. recalls
10 recalls recorded since 2018, most recently on 10 July 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)7
Terminated or completed3
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 10 July 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2971-2026, Z-2972-2026
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Ongoing Class II Medical devices
- Recall started
- 17 June 2026
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2758-2026
- P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.
Ongoing Class II Medical devices
- Recall started
- 13 October 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0871-2026
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Medical devices distributed, prior to sterilization
- Distribution
- US:CA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1256-2024, Z-1255-2024, Z-1254-2024
- Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
- Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
- Phantom TTC Nail, 10.0 X 200mm, Right
Ongoing Class II Medical devices
- Recall started
- 13 July 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1776-2022
- Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Ongoing Class II Medical devices
- Recall started
- 26 May 2022
- Reason
- Due to Titanium plasma coating not present implant.
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1468-2022
- HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Ongoing Class II Medical devices
- Recall started
- 18 May 2022
- Reason
- Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
- Distribution
- International distribution in the country of UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1458-2022
- Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Terminated Class II Medical devices
- Recall started
- 30 July 2021
- Terminated
- 15 December 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2488-2021
- Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Terminated Class II Medical devices
- Recall started
- 28 September 2018
- Terminated
- 20 August 2020
- Reason
- 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, VT, WA, WI, WY OUS: Australia & Israel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0662-2020
- P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
Terminated Class II Medical devices
- Recall started
- 19 December 2017
- Terminated
- 15 January 2021
- Reason
- 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, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2261-2018
- P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.