Paragon 28 recalls

Paragon 28 has 13 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 26 Aug 2026. 10 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls13since 2018

Last 12 months4reported

Class I00% of total

Ongoing10latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 1Jul 2 0

Severity split

Class I 0 0%Class II 11 85%Class III 2 15%

Why paragon 28 is recalled

Product types

By year

2026323%
202518%
2024323%
2022323%
202118%
201918%
201818%

Ongoing paragon 28 recalls

10 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS III	Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev recalled	Paragon 28	Other	Nationwide
26 Aug 2026Device	CLASS III	Custom Made Device Implant 6123 Navicular Cage Small Right Rev recalled	Paragon 28	Other	Nationwide
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
10 Dec 2025Device	CLASS II	Phantom Fibula Nail, Right, Ti, Fibula Nail recalled by Paragon 28	Paragon 28	Potency & Assay	Nationwide
13 Mar 2024Device	CLASS II	Phantom TTC Nail, 0, Right recalled by Paragon 28	Paragon 28	Sterility	CA
13 Mar 2024Device	CLASS II	Phantom TTC Nail, TTC Nail, 0, Right recalled by Paragon 28	Paragon 28	Sterility	CA

All paragon 28 recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS III	Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev recalled	Paragon 28	Other	Nationwide
26 Aug 2026Device	CLASS III	Custom Made Device Implant 6123 Navicular Cage Small Right Rev recalled	Paragon 28	Other	Nationwide
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
10 Dec 2025Device	CLASS II	Phantom Fibula Nail, Right, Ti, Fibula Nail recalled by Paragon 28	Paragon 28	Potency & Assay	Nationwide
13 Mar 2024Device	CLASS II	Phantom TTC Nail, 0, Right recalled by Paragon 28	Paragon 28	Sterility	CA
13 Mar 2024Device	CLASS II	Phantom TTC Nail, TTC Nail, 0, Right recalled by Paragon 28	Paragon 28	Sterility	CA
13 Mar 2024Device	CLASS II	Phantom TTC Nail, TTC Nail, 5, Right recalled by Paragon 28	Paragon 28	Sterility	CA
28 Sep 2022Device	CLASS II	Grappler Suture Anchor, Titanium, 0, Sterile Kit recalled by Paragon 28	Paragon 28	Lead & Heavy Metals	Nationwide
3 Aug 2022Device	CLASS II	System: Baby Gorilla/Gorilla Plating System recalled by Paragon 28	Paragon 28	Labeling Errors	Nationwide
3 Aug 2022Device	CLASS II	HammerTube Implant, 10¿ Cannulated (Sterile) recalled by Paragon 28	Paragon 28	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.