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Lower risk Medical device recall · FDA · Published July 30, 2018

Zimmer Natural Nail Tibial Nail - 8.3mm vs 12mm Size Error

Zimmer Biomet recalls Yellow 8.3mm Tibial Nails (Model 47249534008) that are actually 12mm. This size error may cause improper bone fixation during fracture treatment.

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

🇺🇸 FDA recall #Z-3246-2018Medical deviceZimmer Biomet ›
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Contact the company

Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer Biomet recalls Yellow 8.3mm Tibial Nails (Model 47249534008) that are actually 12mm in size. This size error could lead to improper bone fixation during fracture treatment, potentially causing complications. Read more at govinfonow.com/recall/70281-zimmer-natural-nail-tibial-nail-8-3mm-vs-12mm-size.

Source Summary by GovInfoNow · govinfonow.com/recall/70281-zimmer-natural-nail-tibial-nail-8-3mm-vs-12mm-size · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3246-2018

Cite this page

“Zimmer Natural Nail Tibial Nail - 8.3mm vs 12mm Size Error.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70281-zimmer-natural-nail-tibial-nail-8-3mm-vs-12mm-size. Based on FDA recall #Z-3246-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3246-2018%22&limit=1).

The FDA announced on July 30, 2018, that Zimmer Biomet, Inc. voluntarily recalled a Zimmer Natural Nail Tibial Nail due to mislabeling hazards. The device was distributed in the Netherlands and not in the United States.

How to tell if you have it

  • Brand: Zimmer Biomet
  • Product: Zimmer Natural Nail Tibial Nail - Yellow 8.3mm
  • Model Number: 47249534008
  • UPC: 00889024097551
  • Lot Code: 61169228R

The hazard

The item is labeled as an 8.3mm, but it is actually a 12 mm. The product was not distributed in the United States.

Context

GovInfoNow's records show Zimmer Biomet has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include the Zimmer Affixus Femoral Nails Recall (Dec. 2, 2025) and the Zimmer Affixus Antegrade Femoral Nails Recall (Dec. 2, 2025).

How to tell if you have this one

Check for Yellow 8.3mm Tibial Nails with Model Number 47249534008. These were sold for temporary fracture fixation of the tibia.

  • Brand
    Zimmer Biomet
  • Product
    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the model number 47249534008 on the product packaging or label.

How this recall unfolded

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Jul 30, 201812. FDA classified it Class II: Sep 25, 201823. Published in FDA’s Enforcement Report: Oct 3, 201834. FDA terminated the recall: Oct 24, 2019420182019
  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

Is this product dangerous?

The size error could lead to improper bone alignment, but the recall indicates low risk as it's a labeling issue rather than a safety hazard.

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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-3246-2018 (July 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3246-2018 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.
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