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Lower risk Medical device recall · FDA · Published May 18, 2018

Implant Direct REPLANT 5.0mmD ABUTMENT: Clinician Fitting Risk

Implant Direct recalls REPLANT 5.0mmD ABUTMENT (part 6050-52-60) due to fitting issues. Affected lots: 45353, 66011, : 75850. Clinicians may not properly attach implants.

🇺🇸 FDA recall #Z-2376-2018Medical deviceImplant Direct ›
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Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Thousand Oaks, CA 91362
✎ GovInfoNow plain-language explainer

What happened, in plain English

Implant Direct is recalling REPLANT 5.0mmD ABUTMENT parts because they don't fit properly with dental implants. This could prevent dentists from correctly attaching implants, which is important for dental health. Read more at govinfonow.com/recall/71027-implant-direct-replant-5-0mmd-abutment-clinician-fitting-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71027-implant-direct-replant-5-0mmd-abutment-clinician-fitting-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2376-2018

Cite this page

“Implant Direct REPLANT 5.0mmD ABUTMENT: Clinician Fitting Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71027-implant-direct-replant-5-0mmd-abutment-clinician-fitting-risk. Based on FDA recall #Z-2376-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2376-2018%22&limit=1).

Why it’s dangerous

The abutment parts are out of specification, meaning dentists cannot properly attach them to dental implants. This could lead to improper implant fitting, which might affect the stability and success of the dental procedure.

Who’s affected

Dentists and dental clinics using the recalled REPLANT 5.0mmD ABUTMENT parts (lot numbers 45353, 66011, 75850) are most at risk. Patients receiving dental implants with these parts may not get proper treatment.

How to tell if you have this one

Check if your abutment has part number 6050-52-60 and lot numbers 45353, 66011, or 75850. These parts are used in dental implant procedures.

  • Brand
    Implant Direct
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify your abutment's part number and lot number to see if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed in 16 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: not listedIDMontana: yesMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: yesSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: 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: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Georgia, Illinois, Louisiana, Michigan, Montana, New Jersey, New York, North Carolina, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: May 18, 201812. FDA classified it Class II: Jul 5, 201823. Published in FDA’s Enforcement Report: Jul 11, 201834. FDA terminated the recall: Jul 13, 2020420182020
  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-2376-2018 (May 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2376-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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