Nobel Biocare Usa Llc recalls NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)121291…

Recall date

August 28, 2019

Source

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

Recall number

Z-1851-2020

FDA classification

Class II

Brand / firm

Nobel Biocare Usa Llc

Sold / distributed

International distribution - the country Russia only.

Why it was recalled

The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

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

What was recalled

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.