Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NobelActive Internal NP 3.5x15mm Endosseus dental implant Recalled by Nobel Biocare Usa Llc Due to The top label for dental implant may incorrectly...

Date: July 19, 2019
Company: Nobel Biocare Usa Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare Usa Llc directly.

Affected Products

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

Quantity: 221 implants

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 28 states: AL, AZ, AR, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MI, MS, MO, NV, NH, NY, NC, OK, PA, SC, SD, TX, UT, WA, WI

Affected (28 states)Not affected

About Nobel Biocare Usa Llc

Nobel Biocare Usa Llc has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report