Paragon 28 recalls
Paragon 28 appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2018-06-27 to 2026-08-26 |
| By agency | FDA Device (13) |
| By classification | Class II (11), Class III (2) |
| By status | ongoing (10), terminated (3) |
| Distribution named in notices | AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, US, VT, WA, WI, WY |
Recalls
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R
FDA Device · Class III · 2026-08-26 · Paragon 28
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. - Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R
FDA Device · Class III · 2026-08-26 · Paragon 28
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. - P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-…
FDA Device · Class II · 2026-07-29 · Paragon 28
Reason: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. - Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Device · Class II · 2025-12-10 · Paragon 28
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 b… - Phantom TTC Nail, 10.0 X 200mm, Right
FDA Device · Class II · 2024-03-13 · Paragon 28
Reason: Medical devices distributed, prior to sterilization - Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
FDA Device · Class II · 2024-03-13 · Paragon 28
Reason: Medical devices distributed, prior to sterilization - Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
FDA Device · Class II · 2024-03-13 · Paragon 28
Reason: Medical devices distributed, prior to sterilization - Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
FDA Device · Class II · 2022-09-28 · Paragon 28
Reason: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. - Paragon 28, Inc
FDA Device · Class II · 2022-08-03 · Paragon 28
Reason: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. - HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
FDA Device · Class II · 2022-08-03 · Paragon 28
Reason: Due to Titanium plasma coating not present implant. - Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
FDA Device · Class II · 2021-09-29 · Paragon 28
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. - P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Us…
FDA Device · Class II · 2019-12-18 · Paragon 28
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 pre… - P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot…
FDA Device · Class II · 2018-06-27 · Paragon 28
Reason: Missing drill guide as stated in the package.