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Lower risk Medical device recall · FDA · Published August 28, 2019

Nobel Biocare Dental Implant Recall: Incorrect Length Labeling Risk

Nobel Biocare recalls 3.75x10mm dental implants with incorrect 7mm length label on packaging. This could lead to improper fit during surgery. Affected units have specific lot numbers and serial codes.

🇺🇸 FDA recall #Z-1851-2020Medical deviceNobel Biocare ›
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Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609
✎ GovInfoNow plain-language explainer

Nobel Biocare is recalling certain dental implants that may have a label showing a shorter length than actual. This could cause improper fitting during surgery if used without checking the correct size. Read more at govinfonow.com/recall/67090-nobel-biocare-dental-implant-recall-incorrect-length-labeling-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67090-nobel-biocare-dental-implant-recall-incorrect-length-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1851-2020

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“Nobel Biocare Dental Implant Recall: Incorrect Length Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67090-nobel-biocare-dental-implant-recall-incorrect-length-labeling-risk. Based on FDA recall #Z-1851-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1851-2020%22&limit=1).

The FDA announced on 2019-08-28 that Nobel Biocare Usa Llc is recalling NobelParallel Conical Connection NP dental implants because labels may incorrectly indicate a shorter length than the actual implant. This Class II recall affects products distributed in Russia.

How to tell if you have it

  • NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant)
  • REF 37965
  • UPC 07332747091441
  • Lot 12129104

The hazard

The top label of article no. 37965, lot 12129104 may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

Context

GovInfoNow's records show Nobel Biocare Usa Llc has 6 other recalls on record since 2018-03-16. Other recent recalls of similar products include NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 (2021-12-17), Nobel Biocare Temporary Abutment Screws May Loosen (2019-08-09), and NobelActive Dental Implant Recall (2019-07-19). Other recent recalls of similar products include Straumann Bone Level Tapered Implant May Be Wrong Length (2026-07-16), Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08), and Straumann GM Helix Implant Recall (2026-08-12).

How to tell if you have this one

Check for the product code REF 37965 with lot number 12129104 on the packaging. The implant is a 3.75x10mm endosseous dental implant for jaw bone support.

  • Brand
    Nobel Biocare
  • Product
    NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Label

    Look for the lot number 12129104 and product code REF 37965 on the implant packaging.

How this recall unfolded

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Aug 28, 201912. FDA classified it Class II: May 4, 202023. Published in FDA’s Enforcement Report: May 13, 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

Is there a risk of injury from this implant?

The recall is for potential improper fitting during surgery, not a direct injury risk. The hazard is low risk as it requires specific conditions to cause issues.

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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-1851-2020 (August 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1851-2020 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