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.

Incorrect drill protocol in the Instructions for Use (IFU)

The firm, Nobel Biocare, sent "IMPORTANT-QUALITY MESSAGE" Field Correction Letters and response forms dated July 22, 2016. The letter describes the product, problem and actions to be taken and informs the customers that the titles of the IFU and the Manual are "NobelGuide for NobelParallel Conical Connection" (ID number 2002) and "Guided Surgery with Nobel Parallel Conical Connection" (ID number 79423). The Customers are instructed to review if you have a printed version of the IFU or the Manual related to the article and discard them; and to complete the attached "Quality Message Acknowledgement" form and fax to 714-998-9348 or email to: [email protected]. Customers are informed that an English version of the corrected IFU is attached to the letter and translated versions will be available on the Nobel Biocare website for electronic IFU's http://www.nobelbiocare.com/IFU within 30 days. If you have further questions, contact our customer service department at 714-322-5001.