Use caution Medical device recall · FDA · Published July 19, 2019

NobelActive Dental Implant Recall: Incorrect Length Label Risk

Nobel Biocare recalls 3.5x15mm Endosseus dental implants with potentially incorrect length labels that could cause nerve damage or extra surgery.

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

🇺🇸 FDA recall #Z-2207-2020Medical device Nobel Biocare ›

Use caution until it’s fixed

The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Take action

Contact the company

Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609

✎ GovInfoNow plain-language explainer

Nobel Biocare is recalling dental implants that may have labels showing a shorter length than actual. This could lead to patient discomfort, nerve damage, or needing additional surgery. Read more at govinfonow.com/recall/67376-nobelactive-dental-implant-recall-incorrect-length-label-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67376-nobelactive-dental-implant-recall-incorrect-length-label-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2207-2020

Cite this page

“NobelActive Dental Implant Recall: Incorrect Length Label Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67376-nobelactive-dental-implant-recall-incorrect-length-label-risk. Based on FDA recall #Z-2207-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2207-2020%22&limit=1).

Nobel Biocare USA LLC voluntarily recalled NobelActive Internal NP 3.5x15mm Endosseus dental implants on July 19, 2019, according to the FDA. The agency announced that incorrect labeling may cause patient discomfort or nerve damage.

How to tell if you have it

Brand: Nobel Biocare
Product: NobelActive Internal NP 3.5x15mm Endosseus dental implant
REF: 34128
UDI: (01)07332747010619
UPC: 07332747010619
Lot number: 13080792

The hazard

The top label for the dental implant may incorrectly indicate a length of 11.5mm instead of the actual 15mm length, according to the FDA. An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Context

GovInfoNow's records show Nobel Biocare USA LLC has had six other recalls since March 16, 2018. Other recent recalls of similar products include NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 (Dec. 17, 2021), Nobel Biocare Dental Implant Recall (Aug. 28, 2019), and Nobel Biocare Temporary Abutment Screws May Loosen - Recall (Aug. 9, 2019). Other recent recalls of similar products include Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (July 16, 2026), Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (June 8, 2026), and Micro Therapeutics Pipeline Flex Embolization Device Labeling Error (June 8, 2026).

How to tell if you have this one

Check for the implant model '3.5x15mm Endosseus' with reference number 34128. The implant was sold with a unique identifier (UDI) starting with (01)07332747010619.

Brand
Nobel Biocare
Product
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Implant Label
Look for the label indicating the implant length; it should be 15mm, not 11.5mm.

Where it went and when

Where it was distributed

Distributed in 28 states.

FDA distribution: “US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, Missouri, Nevada, New Hampshire, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Jul 19, 2019Firm started the recall
Jun 2, 2020FDA classified it Class II
Jun 10, 2020Published in FDA’s Enforcement Report
Oct 27, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Nobel Biocare recalls

Link to this recall

<a href="https://govinfonow.com/recall/67376-nobelactive-dental-implant-recall-incorrect-length-label-risk">NobelActive Dental Implant Recall: Incorrect Length Label Risk (GovInfoNow)</a>

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-2207-2020 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2207-2020 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.