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Paragon 28, Inc. FDA Recalls

11 recalls on file across devices, 0 of them Class I and 10 still open. Matched by name to FNA.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implantClass IIIJul 10, 2026Device was recalled due to an elevated oxygen level in exces	Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels m	Class IIIDevices	Jul 10, 2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implantClass IIIJul 10, 2026Device was recalled due to an elevated oxygen level in exces	Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels m	Class IIIDevices	Jul 10, 2026
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, IClass IIJun 17, 2026Paragon 28 received two (2) complaints were received involvi	Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch pa	Class IIDevices	Jun 17, 2026
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SClass IIOct 13, 2025Fibula nail system intended for use in fixation of fibular f	Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification	Class IIDevices	Oct 13, 2025
Phantom TTC Nail, 10.0 X 200mm, RightClass IIDec 21, 2023Medical devices distributed, prior to sterilization	Medical devices distributed, prior to sterilization	Class IIDevices	Dec 21, 2023
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LClass IIDec 21, 2023Medical devices distributed, prior to sterilization	Medical devices distributed, prior to sterilization	Class IIDevices	Dec 21, 2023
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RClass IIDec 21, 2023Medical devices distributed, prior to sterilization	Medical devices distributed, prior to sterilization	Class IIDevices	Dec 21, 2023
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture AnchClass IIJul 13, 2022Suture anchor may break upon insertion, which could lead to	Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery	Class IIDevices	Jul 13, 2022
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)Class IIMay 26, 2022Due to Titanium plasma coating not present implant.	Due to Titanium plasma coating not present implant.	Class IIDevices	May 26, 2022
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill,Class IIMay 18, 2022Incorrect labeling; There is potential that the drill packa	Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.	Class IIDevices	May 18, 2022
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630Class IIJul 30, 2021A thin wall condition between the inner cannulation and the	A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause	Class IIDevices	Jul 30, 2021

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