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Lower risk Medical device recall · FDA · Published October 30, 2020

Neocis Gen 2 Anterior Chairside Splint Mislabeling Recall

Neocis recalls Gen 2 Anterior Chairside Splints due to possible mislabeling. Affected units may not be correctly identified, but no safety risk is reported.

🇺🇸 FDA recall #Z-0929-2021Medical deviceNeocis ›
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Recalling firmNeocis, Inc.530 NW 29th St · Miami, FL 33127-3917
✎ GovInfoNow plain-language explainer

What happened, in plain English

Neocis is recalling Gen 2 Anterior Chairside Splints that may be mislabeled. This could lead to incorrect identification of the product, but there is no stated safety risk. Read more at govinfonow.com/recall/64027-neocis-gen-2-anterior-chairside-splint-mislabeling-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/64027-neocis-gen-2-anterior-chairside-splint-mislabeling-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0929-2021

Cite this page

“Neocis Gen 2 Anterior Chairside Splint Mislabeling Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64027-neocis-gen-2-anterior-chairside-splint-mislabeling-recall. Based on FDA recall #Z-0929-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0929-2021%22&limit=1).

Why it’s dangerous

The splints may be mislabeled, meaning they could be incorrectly identified. This could lead to confusion about which splint is being used, but the recall does not indicate any safety hazard.

Who’s affected

Dentists and dental clinics using Neocis Gen 2 Anterior Chairside Splints. Patients using these splints are at minimal risk if the mislabeling does not affect product function.

How to tell if you have this one

Check for the model number DRW-073:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left) on the product. The recall covers accessories to the Neocis Guidance System (NGS) with Work Order (Lot) Number 1573.

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

What to do — step by step

  1. Check Product Label

    Look for the model number DRW-073:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left) on the product.

Where it went and when

Where it was distributed

Distributed in 7 states.

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: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew 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: yesFL

FDA distribution: “OH, FL, CT, MA, AZ PA, NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Connecticut, Florida, Massachusetts, New York, Ohio, Pennsylvania.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Oct 30, 202012. FDA classified it Class II: Jan 26, 202123. Published in FDA’s Enforcement Report: Feb 3, 202134. FDA terminated the recall: Aug 11, 2021420202021
  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-0929-2021 (October 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0929-2021 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