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Unrated Medical device recall · FDA · Published May 2, 2023

Sybron Legacy Smartbase Recalls: Unapproved Non-Engaging Abutments

Sybron recalls Legacy Smartbase dental implants with unapproved non-engaging abutments that lack FDA clearance. Consumers should contact Sybron for details on affected models and remedies.

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

🇺🇸 FDA recall #Z-2037-2023Medical deviceSybron ›
Take action

Contact the company

Recalling firmImplant Direct Sybron Manufacturing LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
✎ GovInfoNow plain-language explainer

Sybron is recalling specific Legacy Smartbase dental implants because they were distributed without FDA clearance and their performance characteristics are not yet established. This could pose risks during dental procedures if the implants don't engage properly. Read more at govinfonow.com/recall/58478-sybron-legacy-smartbase-recalls-unapproved-non-engaging-abutments.

Source Summary by GovInfoNow · govinfonow.com/recall/58478-sybron-legacy-smartbase-recalls-unapproved-non-engaging-abutments · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2037-2023

Cite this page

“Sybron Legacy Smartbase Recalls: Unapproved Non-Engaging Abutments.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58478-sybron-legacy-smartbase-recalls-unapproved-non-engaging-abutments. Based on FDA recall #Z-2037-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2037-2023%22&limit=1).

The FDA announced on May 2, 2023, that Implant Direct Sybron Manufacturing LLC is recalling LEGACY SMARTBASE dental implants due to non-engaging abutments distributed without clearance. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Sybron
  • Product: LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE
  • Product: LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE
  • Product: LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE
  • Product: LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE
  • Product: LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE
  • Product: LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE
  • Lot codes: 92637, 131309, 92638, 163063, 160542, 15002360, 15004780, 182029
  • Distribution: US Nationwide in FL, ID, TX, CA

The hazard

The recall involves non-engaging abutments distributed without FDA clearance. The performance characteristics of these devices have not yet been adequately established.

Context

GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has 20 other recalls on record since June 26, 2017. Other recent recalls include the May 1, 2025 Sybron Drill Stop Kit Recall for incorrect components and the Sept. 23, 2021 ImplantDirect Legacy 2 recall for incorrect size labeling. Similar product recalls announced on Feb. 27, 2026, include Medline Convenience Kits with unapproved syringes.

How to tell if you have this one

Check for the model names: Legacy Smartbase NE 3.0D 1MML, NE 3.0D 2MML, or Legacy Smartbase Narrow. Look for the reference codes: 8730-81NE, 8730-82NE, 8735-80NNE, 8735-82NE, 8745-80NNE, or 8745-82NE.

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

What to do — step by step

  1. Contact Sybron

    Reach out to Sybron directly to confirm if your specific Legacy Smartbase model is affected and get instructions on next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, ID, TX, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Idaho, Texas.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: May 2, 202312. FDA classified it Class II: Jun 29, 202323. Published in FDA’s Enforcement Report: Jul 5, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2037-2023 (May 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2037-2023 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