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.

• 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
• 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
• 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
• 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
• Phantom TTC Nail, 10.0 X 200mm, Right
  FDA Device · Class II · 2024-03-13 · Paragon 28
• Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
  FDA Device · Class II · 2024-03-13 · Paragon 28
• Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
  FDA Device · Class II · 2024-03-13 · Paragon 28
• 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
• Paragon 28, Inc
  FDA Device · Class II · 2022-08-03 · Paragon 28
• HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
  FDA Device · Class II · 2022-08-03 · Paragon 28
• 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
• 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
• 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