The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2207-2020·Announced 2020-06-10

Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling

Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect may cause 'permanent nerve damage' and 'additional surgery,' which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4 (Severe).

Plain-English summary

Nobel Biocare USA LLC is recalling 221 units of NobelActive Internal NP 3.5x15mm Endosseus dental implants (REF: 34128, Lot 13080792). The recall was initiated because the top label for the 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).

The FDA has classified this as a Class II recall. An incorrectly sized implant may cause patient discomfort, permanent nerve damage, and may require an additional surgery. The affected products were distributed in the United States to the following states: 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, and WI. No distribution outside the United States is reported.

Healthcare providers and patients should check their records for implants with REF 34128 and Lot number 13080792. If you have received or used these specific implants, contact your healthcare provider or Nobel Biocare for further instructions on how to proceed.

The recalled product

Product
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
221

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number: 13080792

Distribution

Distributed in 28 states:

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