Class II — Potential Health Hazard

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

Replace Select Tapered TiU NP 3.5x11.5mm Recalled by Nobel Biocare Usa Llc Due to Incorrect top label on an implant package.

Date: June 22, 2016
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

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.

Quantity: 53 units total (33 units in US)

Why Was This Recalled?

Incorrect top label on an implant package.

Where Was This Sold?

This product was distributed to 4 states: NY, OH, OR, SC

Affected (4 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