Lower risk Medical device recall · FDA · Published September 28, 2018

Paragon 28 Recalls 10mm Wedge Implant Kit Due to Size Mislabeling

Paragon 28 recalls 10mm wedge implant kits labeled as 12mm to prevent surgical errors. The mislabeling risks improper surgical site preparation and delays in procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0662-2020Medical device Paragon 28 ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmParagon 28, Inc.4B Inverness Ct E Ste 280 · Englewood, CO 80112-5329

✎ GovInfoNow plain-language explainer

Paragon 28 is recalling 10mm wedge implant kits that are incorrectly labeled as 12mm. Using these kits could cause surgical site preparation errors and delay procedures. Read more at govinfonow.com/recall/69718-paragon-28-recalls-10mm-wedge-implant-kit-due-to-size.

Source Summary by GovInfoNow · govinfonow.com/recall/69718-paragon-28-recalls-10mm-wedge-implant-kit-due-to-size · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0662-2020

Cite this page

“Paragon 28 Recalls 10mm Wedge Implant Kit Due to Size Mislabeling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69718-paragon-28-recalls-10mm-wedge-implant-kit-due-to-size. Based on FDA recall #Z-0662-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2020%22&limit=1).

The FDA announced on Sept. 28, 2018, that Paragon 28, Inc. is recalling P28 Titan 3-D Wedge implants due to permanent mislabeling of the size. The hazard involves improper surgical site preparation and potential delays in surgery.

How to tell if you have it

Brand: Paragon 28
Product: P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile
REF: P03-EVN-1010-S
UPC: 00889795018182
Lot: BR4108

The hazard

The wedge implant kit is permanently mislabeled with the wrong size, marked as 12mm instead of 10mm. Use of the product could result in improper preparation of the surgical site causing delays in surgery.

Context

GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since Dec. 19, 2017. Other recent recalls include a Custom Foot Implant recall for elevated oxygen risk (July 10, 2026) and a P28 Phantom Hindfoot Nail System packaging breach risk (June 17, 2026). Similar recent recalls of similar products include an EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026).

How to tell if you have this one

Check for the product name 'P28 Titan 3-D Wedge, Evans, Large, 10 mm, sterile' with the reference number P03-EVN-1010-S. The kit is labeled as 12mm but is a 10mm size.

Brand
Paragon 28
Product
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Verify the size label on the kit; it should read 10mm, not 12mm.

Where it went and when

Where it was distributed

Distributed in 33 states and D.C., and outside the U.S.

FDA distribution: “AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY OUS: Australia & Israel” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Sep 28, 2018Firm started the recall
Dec 10, 2019FDA classified it Class II
Dec 18, 2019Published in FDA’s Enforcement Report
Aug 20, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall is for potential surgical delays, not direct injury risks. The hazard is low risk as it only affects procedure timing.

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Link to this recall

<a href="https://govinfonow.com/recall/69718-paragon-28-recalls-10mm-wedge-implant-kit-due-to-size">Paragon 28 Recalls 10mm Wedge Implant Kit Due to Size Mislabeling (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0662-2020 (September 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0662-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.