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U.S. Department of Health and Human Services

Class 2 Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit

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  Class 2 Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit see related information
Date Initiated by Firm July 20, 2016
Create Date August 09, 2016
Recall Status1 Terminated 3 on October 17, 2016
Recall Number Z-2375-2016
Recall Event ID 74782
510(K)Number K990846  
Product Classification Drill, bone, powered - Product Code DZI
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.
Code Information Article 38072-all lots
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715/22725 Savi Ranch Pkwy
Yorba Linda CA 92887
For Additional Information Contact Joann Radovich
714-282-4800 Ext. 7833
Manufacturer Reason
for Recall		 Incorrect drill protocol in the Instructions for Use (IFU)
FDA Determined
Cause 2		 Labeling design
Action 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: joann.radovich@nobelbiocare.com. 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.
Quantity in Commerce 231 kits
Distribution Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZI and Original Applicant = NOBEL BIOCARE UAS INC
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