Nobel Biocare Usa Llc recalls Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous imp…

Recall date

March 9, 2015

Source

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

Recall number

Z-1416-2015

FDA classification

Class II

Brand / firm

Nobel Biocare Usa Llc

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway…

Why it was recalled

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

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 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.