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Lower risk Medical device recall · FDA · Published August 9, 2019

Nobel Biocare Esthetic Abutment CC RP 1.5mm: Incorrect Screw Risk

Nobel Biocare recalls Esthetic Abutment CC RP 1.5mm dental implants due to potential screw loosening. Affected units may require retightening with correct screws to prevent complications.

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

🇺🇸 FDA recall #Z-1854-2020Medical deviceNobel Biocare ›
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Contact the company

Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609
✎ GovInfoNow plain-language explainer

Nobel Biocare is recalling Esthetic Abutment CC RP 1.5mm dental implants because some packages contain incorrect screws that may loosen over time. This could lead to the abutment needing retightening to avoid complications during dental procedures. Read more at govinfonow.com/recall/67232-nobel-biocare-esthetic-abutment-cc-rp-1-5mm-incorrect-screw.

Source Summary by GovInfoNow · govinfonow.com/recall/67232-nobel-biocare-esthetic-abutment-cc-rp-1-5mm-incorrect-screw · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1854-2020

Cite this page

“Nobel Biocare Esthetic Abutment CC RP 1.5mm: Incorrect Screw Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67232-nobel-biocare-esthetic-abutment-cc-rp-1-5mm-incorrect-screw. Based on FDA recall #Z-1854-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2020%22&limit=1).

Nobel Biocare Usa Llc recalled Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components on Aug. 9, 2019, after the FDA announced that packages may contain an incorrect screw that could loosen. The Food and Drug Administration issued the recall under agency number Z-1854-2020.

How to tell if you have it

  • Brand: Nobel Biocare
  • Product: Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant
  • Catalog no.: 36669
  • Lot no.: 13077560
  • UPC: 07332747032598

The hazard

The FDA stated that packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that it will not loosen, requiring the abutment to be retightened with the correct screw.

Context

GovInfoNow's records show Nobel Biocare Usa Llc has had six other recalls since March 16, 2018. Recent brand recalls include a Dec. 17, 2021 recall for NobelReplace Conical Connection RP implants due to incorrect offset and an Aug. 28, 2019 recall for Nobel Biocare dental implants involving incorrect length labeling. Other recent recalls of similar products include a March 27, 2026 Straumann Dental Implant Abutments Recall for incorrect screw seat interface hazard and a July 13, 2026 Straumann GM Helix Dental Implant Recall for packaging mismatch risk.

How to tell if you have this one

Check for catalog number 36669 and lot number 13077560 on the packaging. The product is a dental implant abutment used for supporting tooth replacements in the upper or lower jaw.

  • Brand
    Nobel Biocare
  • Product
    Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
Recall numberProduct, codes & lotsQuantity
Z-1852-2020Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no. 36662, Lot no. 13078005, UDI: (01)07332747034301(10)13078005236
Z-1853-2020Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no. 36664, Lot no. 13077622, UDI: (01)07332747034301(10)13077622239
Z-1854-2020Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no. 36669, Lot no. 13077560, UDI: (01)07332747032598(10)13077560227 pieces
Z-1855-2020Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no. 36683, Lot no. 13077700, UDI: (01)07332747034264(10)13077700215 pieces
Z-1856-2020Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822238 pieces
Z-1857-2020Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.; Catalog no.38761, Lot numbers 13077550 and 13077551; UDI: (01)07332747115604(10)13077550 and (01)07332747115604(10)13077551478 pieces
Based on the official FDA remedy

What to do — step by step

  1. Check for Correct Screw

    Ensure the screw is tightened properly and can be retightened if it loosens.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 31 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Aug 9, 201912. FDA classified it Class II: May 4, 202023. Published in FDA’s Enforcement Report: May 13, 202034. FDA terminated the recall: Dec 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-1854-2020 (August 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1854-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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