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Lower risk Medical device recall · FDA · Published December 23, 2019

Neodent Tapered Guided Surgery Drill Recall: Incorrect Laser Engraving Label

Neodent recalls a dental burr with incorrect laser engraving that labels it as 4.3+ instead of 4.3 Tapered Guided Surgery Drill. This may cause confusion in dental procedures.

🇺🇸 FDA recall #Z-0924-2020Medical deviceNeodent ›
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Recalling firmJjgc Industria E Comercio De Materials Dentarios SaAv Juscelino Kubitschek De Oliveira · Curitiba, Brazil
✎ GovInfoNow plain-language explainer

What happened, in plain English

Neodent is recalling a specific dental burr model due to incorrect laser engraving that labels it as 4.3+ instead of 4.3. This could lead to confusion during dental procedures. Read more at govinfonow.com/recall/66213-neodent-tapered-guided-surgery-drill-recall-incorrect-laser-engraving-label.

Source Summary by GovInfoNow · govinfonow.com/recall/66213-neodent-tapered-guided-surgery-drill-recall-incorrect-laser-engraving-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0924-2020

Cite this page

“Neodent Tapered Guided Surgery Drill Recall: Incorrect Laser Engraving Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66213-neodent-tapered-guided-surgery-drill-recall-incorrect-laser-engraving-label. Based on FDA recall #Z-0924-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0924-2020%22&limit=1).

Why it’s dangerous

The laser engraving incorrectly identifies the drill as a 4.3+ model instead of 4.3. This labeling error could cause confusion during dental procedures, but it does not pose a physical safety risk.

Who’s affected

Dental professionals who own or use the recalled Neodent Tapered Guided Surgery Drill (Article No. 103.436, UDI 07899878030041) are affected. The risk is low as the issue is a labeling error, not a safety hazard.

How to tell if you have this one

Check for the product name 'Neodent Tapered Guided Surgery Drill', Article No. 103.436, and UDI 07899878030041. The device is a dental burr sold in lot WH723.

  • Brand
    Neodent
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the product label for the correct model designation (4.3 Tapered Guided Surgery Drill) to ensure it matches the recall criteria.

Where it went and when

Where it was distributed

Distributed in California and Pennsylvania.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed to consignees in CA and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Pennsylvania.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Dec 23, 201912. FDA classified it Class II: Jan 31, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Jun 1, 2021420192021
  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.

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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-0924-2020 (December 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0924-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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