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

Recalled August 17, 2016 · FDA recall Z-2375-2016 · Nobel Biocare Usa

Hazard

Incorrect drill protocol in the Instructions for Use (IFU) · FDA Class II

Units

231 kits

Sold at

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

Description

Incorrect drill protocol in the Instructions for Use (IFU)

Product

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.

Manufacturer(s)

Nobel Biocare Usa Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →