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Lower risk Medical device recall · FDA · Published December 19, 2017

Paragon 28 JAWS Nitinol Staple Kits: Missing Drill Guide Hazard

Paragon 28 recalls JAWS Nitinol Staple System kits for foot bone repairs due to missing drill guide in some models. Affected kits include specific part numbers and production lots. Consumers should check their kit details and contact Paragon 28 for guidance.

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

🇺🇸 FDA recall #Z-2261-2018Medical deviceParagon 28 ›
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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 specific JAWS Nitinol Staple System kits used for foot bone repairs because they may be missing the drill guide. This could lead to improper use during surgery. Affected kits have specific part numbers and production lots listed in the recall. Read more at govinfonow.com/recall/72293-paragon-28-jaws-nitinol-staple-kits-missing-drill-guide-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/72293-paragon-28-jaws-nitinol-staple-kits-missing-drill-guide-hazard · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2261-2018

Cite this page

“Paragon 28 JAWS Nitinol Staple Kits: Missing Drill Guide Hazard.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72293-paragon-28-jaws-nitinol-staple-kits-missing-drill-guide-hazard. Based on FDA recall #Z-2261-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2018%22&limit=1).

Paragon 28, Inc. recalled P28 JAWS Nitinol Staple System kits due to missing drill guides in the package, according to the FDA. The agency announced the voluntary Class II recall on Dec. 19, 2017.

How to tell if you have it

  • Brand: Paragon 28
  • Product: P28 JAWS Nitinol Staple System kits
  • Part # P71-008-0808-S (8mm x 8mm x 8mm, Straight) Lots 260315217A, 260322017A, 260326217A and 260326217B
  • Part # P71-010-1010-S (10mm x 10mm x 10mm, Straight) Lots 260317717A, 260317717C, 260322017B, and 260326217D
  • Part # P71-108-0808-S (8mm x 8mm x 8mm, Angled) Lots 260322017C, 260322017D, 260315217B, and 260326217M
  • Part # P71-110-1010-S (10mm x 10mm x 10mm, Angled) Lots 260326217E, 260317717B, 260322017E, 260322017F, 260322017G, 260326217F and 260326217G
  • Sold nationwide in the US and in Australia and South Africa

The hazard

The kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones. The hazard is a missing drill guide as stated in the package.

Context

GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since 2018-09-28. Other recent recalls of similar products include Orthalign Drill Plate Recall: Bone Cut Risk from Manufacturing Defect (2026-02-10), Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall: Plastic Guide Breakage Risk (2026-05-20), and Orthalign Drill Plate Recall: Risk of Bone Cut in Normal Use (2026-02-10).

How to tell if you have this one

Check the part number and production lot on the kit. Affected kits include specific models like P71-008-0808-S (8mm) and P71-108-0808-S (angled) with lots from 260315217A to 260326217G.

  • Brand
    Paragon 28
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Look for the part number and production lot on the kit to determine if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 30 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Dec 19, 201712. FDA classified it Class II: Jun 20, 201823. Published in FDA’s Enforcement Report: Jun 27, 201834. FDA terminated the recall: Jan 15, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA 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

Do I need to stop using the kit?

The recall does not require immediate stop use; affected kits should be checked for the missing drill guide before use.

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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-2261-2018 (December 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2261-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA