Paragon 28 Recalls
11 recalls on record · June 27, 2018 to July 29, 2026 · Medical Devices
Recalls by year
18
19
21
22
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, I
Hazard: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
December 10, 2025Medical DevicesFDA
Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Hazard: 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.
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Hazard: Medical devices distributed, prior to sterilization
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Hazard: Medical devices distributed, prior to sterilization
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, 10.0 X 200mm, Right
Hazard: Medical devices distributed, prior to sterilization
September 28, 2022Medical DevicesFDA
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 Anch
Hazard: Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
August 3, 2022Medical DevicesFDA
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Hazard: Due to Titanium plasma coating not present implant.
August 3, 2022Medical DevicesFDA
Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill,
Hazard: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
September 29, 2021Medical DevicesFDA
Paragon 28, Inc. recalls Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Hazard: 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.
December 18, 2019Medical DevicesFDA
Paragon 28, Inc. recalls P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, S
Hazard: 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.
June 27, 2018Medical DevicesFDA
Paragon 28, Inc. recalls P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and
Hazard: Missing drill guide as stated in the package.