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Lower risk Medical device recall · FDA · Published October 7, 2019

Sybron Legacy 3 Dental Implant Recall: Incorrect Implants May Cause Surgery Rescheduling

Sybron recalls Legacy 3 dental implants with incorrect sizes that could require surgery rescheduling. Affected units include specific dimensions and lot numbers.

🇺🇸 FDA recall #Z-1041-2020Medical deviceSybron ›
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Contact the company

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

Sybron is recalling Legacy 3 dental implants that may have incorrect sizes, which could lead to surgery rescheduling. This affects patients who received the specific model with the described dimensions and lot number. Read more at govinfonow.com/recall/66873-sybron-legacy-3-dental-implant-recall-incorrect-implants-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/66873-sybron-legacy-3-dental-implant-recall-incorrect-implants-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1041-2020

Cite this page

“Sybron Legacy 3 Dental Implant Recall: Incorrect Implants May Cause Surgery Rescheduling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66873-sybron-legacy-3-dental-implant-recall-incorrect-implants-may-cause. Based on FDA recall #Z-1041-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2020%22&limit=1).

The FDA announced on Oct. 7, 2019, that Sybron Manufacturing LLC voluntarily recalled Legacy 3 Implants because some packages contain incorrect implants, which could lead to surgery rescheduling.

How to tell if you have it

  • Brand: Sybron
  • Product: Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
  • Lot code: 83327
  • Units affected: 72

The hazard

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

Context

GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has had 20 other recalls on record since June 26, 2017. Other recent recalls of similar products include Straumann Bone Level Tapered Implant May Be Wrong Length (July 16, 2026), Straumann Dental Implant Abutments Recall: Incorrect Screw Seat Interface Hazard (March 27, 2026), and Straumann GM Helix Dental Implant Recall: Packaging Mismatch Risk (July 13, 2026).

How to tell if you have this one

Check for the Legacy 3 implant with size 4.2mmD x 13mmL, platform 3.5mmD, and lot number 83327. The product is sold under Sybron Manufacturing LLC.

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

What to do — step by step

  1. Check Implant Details

    Verify the implant size, platform, and lot number to confirm if it matches the recalled model.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 15 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Idaho, Kansas, Louisiana, Massachusetts, Missouri, New Jersey, Ohio, Pennsylvania, Rhode Island, Utah, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Oct 7, 201912. FDA classified it Class II: Feb 5, 202023. Published in FDA’s Enforcement Report: Feb 12, 202034. FDA terminated the recall: Apr 28, 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.

✎ GovInfoNow

Questions people ask

What should I do if I have this implant?

Check the implant details to see if it matches the recalled model; no immediate action is required beyond verification.

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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-1041-2020 (October 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1041-2020 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