Nobel Biocare Usa Llc recalls Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous im…

Recall date

June 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2237-2016

FDA classification

Class II

Brand / firm

Nobel Biocare Usa Llc

Sold / distributed

Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC

Why it was recalled

Incorrect top label on an implant package.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.