Recall Atlas

Paragon recalls

7 official recalls and safety alerts involving Paragon since 2022-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Paragon or the relevant agency.

  1. 2026-08-26
  2. US
    Drugs & medicalClass III

    Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

    Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

    FDA · DeviceParagon 28, Inc.US Nationwide distribution i the state of MT.Official notice →
  3. 2026-07-29
  4. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…

    Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

    FDA · DeviceParagon 28, Inc.US nationwide, Australia, Canada, The Netherlands, and New ZealandOfficial notice →
  5. 2025-12-10
  6. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

    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…

    FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX,…Official notice →
  7. 2024-03-13
  8. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

    Medical devices distributed, prior to sterilization

    FDA · DeviceParagon 28, Inc.US:CA OUS: NoneOfficial notice →
  9. 2022-09-28
  10. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

    Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

    FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD,…Official notice →
  11. 2022-08-03
  12. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

    Due to Titanium plasma coating not present implant.

    FDA · DeviceParagon 28, Inc.U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.Official notice →
  13. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

    Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

    FDA · DeviceParagon 28, Inc.International distribution in the country of UK.Official notice →