--- title: "Paragon 28, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Paragon 28, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/paragon-28-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Paragon 28, Inc. recall records **10** reported ongoing 10 records in this archive. Latest source date Jul 10, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 10, 2026 FDA device enforcement ### [Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant](https://isitonrecall.com/recall/fda-device-z-2971-2026-custom-made-device-implant-6123-navicular-cage-small-right-rev-a-model-catalog-number-6123s-r-foot-i/) Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. Class III Reported ongoing Distribution: US Nationwide distribution i the state of MT. [Official source for Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2971-2026%22) Jul 10, 2026 FDA device enforcement ### [Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant](https://isitonrecall.com/recall/fda-device-z-2972-2026-custom-made-device-implant-6123-navicular-cage-nominal-right-rev-a-model-catalog-number-6123n-r-foot/) Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. Class III Reported ongoing Distribution: US Nationwide distribution i the state of MT. [Official source for Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R;...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2972-2026%22) Jun 17, 2026 FDA device enforcement ### [P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the ...](https://isitonrecall.com/recall/fda-device-z-2758-2026-p28-phanton-intramedullary-nail-system-phantom-hindfoot-ttc-tc-ball-tipped-guide-rod-size-0-30-mm-le/) Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. Class II Reported ongoing Distribution: US nationwide, Australia, Canada, The Netherlands, and New Zealand [Official source for P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2758-2026%22) Oct 13, 2025 FDA device enforcement ### [Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S](https://isitonrecall.com/recall/fda-device-z-0871-2026-phantom-fibula-nail-2-8mm-x-130mm-right-ti-fibula-nail-ref-p36-128-130r-s/) 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... Class II Reported ongoing Distribution: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. [Official source for Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0871-2026%22) Dec 21, 2023 FDA device enforcement ### [Phantom TTC Nail, 10.0 X 200mm, Right](https://isitonrecall.com/recall/fda-device-z-1254-2024-phantom-ttc-nail-10-0-x-200mm-right/) Medical devices distributed, prior to sterilization Class II Reported ongoing Distribution: US:CA OUS: None [Official source for Phantom TTC Nail, 10.0 X 200mm, Right](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1254-2024%22) Dec 21, 2023 FDA device enforcement ### [Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L](https://isitonrecall.com/recall/fda-device-z-1255-2024-phantom-ttc-nail-ttc-nail-10-0-x-150mm-right-ref-p31-600-175l/) Medical devices distributed, prior to sterilization Class II Reported ongoing Distribution: US:CA OUS: None [Official source for Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1255-2024%22) Dec 21, 2023 FDA device enforcement ### [Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R](https://isitonrecall.com/recall/fda-device-z-1256-2024-phantom-ttc-nail-ttc-nail-11-5-x-250mm-right-ref-p31-615-250r/) Medical devices distributed, prior to sterilization Class II Reported ongoing Distribution: US:CA OUS: None [Official source for Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1256-2024%22) Jul 13, 2022 FDA device enforcement ### [Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System](https://isitonrecall.com/recall/fda-device-z-1776-2022-grappler-suture-anchor-titanium-3-0-x-10mm-sterile-kit-ref-p44-110-3010-sk-for-use-within-the-grappl/) Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD, WI, OK, KY, MI, OH, CA, FL, KS, PA. [Official source for Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within t...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1776-2022%22) May 26, 2022 FDA device enforcement ### [HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)](https://isitonrecall.com/recall/fda-device-z-1468-2022-hammertube-implant-2-75mm-10-cannulated-sterile/) Due to Titanium plasma coating not present implant. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY. [Official source for HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1468-2022%22) May 18, 2022 FDA device enforcement ### [Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm](https://isitonrecall.com/recall/fda-device-z-1458-2022-paragon-28-inc-system-baby-gorilla-gorilla-plating-system-ref-p99-100-2816-material-stainless-steel/) Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. Class II Reported ongoing Distribution: International distribution in the country of UK. [Official source for Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainl...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1458-2022%22) ## Reasons in these listed records - Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. - Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. - 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 instrumen... - Medical devices distributed, prior to sterilization These examples come from this result page and are not a ranking of every recall reason. ## Checking Paragon 28, Inc. ### Is there a recall on paragon 28, inc. right now? This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Paragon 28, Inc.](https://isitonrecall.com/check/?q=Paragon%2028%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)