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Lower risk Medical device recall · FDA · Published March 12, 2018

Zimmer Biomet Phoenix Tibia Nail 3.5mm Inserter Recall: Risk of Fracturing and Remaining

Zimmer Biomet recalls certain Phoenix Tibia Nail 3.5mm Inserter instruments manufactured before March 30, 2017 due to reports of fracturing and remaining in the device implant after surgery.

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

🇺🇸 FDA recall #Z-1236-2018Medical deviceZimmer Biomet ›
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Contact the company

Recalling firmZimmer Biomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling certain Phoenix Tibia Nail 3.5mm Inserter instruments that were manufactured before March 30, 2017. These instruments have been reported to fracture and remain in the device implant after surgery, which could cause serious complications. Read more at govinfonow.com/recall/71734-zimmer-biomet-phoenix-tibia-nail-3-5mm-inserter-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71734-zimmer-biomet-phoenix-tibia-nail-3-5mm-inserter-recall-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1236-2018

Cite this page

“Zimmer Biomet Phoenix Tibia Nail 3.5mm Inserter Recall: Risk of Fracturing and Remaining.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71734-zimmer-biomet-phoenix-tibia-nail-3-5mm-inserter-recall-risk. Based on FDA recall #Z-1236-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2018%22&limit=1).

The FDA announced on March 12, 2018, that Zimmer Biomet, Inc. is recalling certain Phoenix Nail System instruments due to reports of fracturing and remaining in the device implant. The agency issued recall number Z-1236-2018 for the voluntary Class II recall.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: Phoenix Tibia Nail 3.5mm Inserter instruments
  • Model Number: 14-441045
  • Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
  • Lots manufactured before March 30, 2017
  • Units affected: 2470

The hazard

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant, according to the FDA.

Context

GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include Zimmer Biomet Spinal Rod Cutter Recall (Nov. 20, 2020), Zimmer Biomet Polaris 5.5 Spinal System Recall (Nov. 17, 2020), and Zimmer Biomet Hip Cup Recall (Sept. 24, 2020). Other recent recalls of similar products include Zimmer Affixus Antegrade Femoral Nails Recall (Dec. 2, 2025), Zimmer Affixus Femoral Nails Recall (Dec. 2, 2025), and another Zimmer Affixus Femoral Nails Recall (Dec. 2, 2025).

How to tell if you have this one

Check the packaging lot numbers on the instrument, which are listed in the recall notice. The instruments were manufactured before March 30, 2017 and have specific model numbers including 14-441045 and others.

  • Brand
    Zimmer Biomet
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Zimmer Biomet directly to confirm if your instrument is part of the recall and to get instructions on next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 37 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth 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: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution: US (nationwide) AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and countries of: Australia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Mar 12, 201812. Published in FDA’s Enforcement Report: Apr 4, 201823. FDA classified it Class II: Apr 6, 201834. FDA terminated the recall: Nov 18, 2019420182019
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class II
  4. FDA terminated the recall

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

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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-1236-2018 (March 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1236-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 27, 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