Nobel Biocare Usa Llc recalls Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelPar…

Recall date

July 20, 2016

Source

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

Recall number

Z-2375-2016

FDA classification

Class II

Brand / firm

Nobel Biocare Usa Llc

Sold / distributed

Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.

Why it was recalled

Incorrect drill protocol in the Instructions for Use (IFU)

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

What was recalled

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.