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U.S. Department of Health and Human Services

Class 2 Device Recall Replace Select Tapered TiU NP

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  Class 2 Device Recall Replace Select Tapered TiU NP see related information
Date Initiated by Firm March 09, 2015
Date Posted April 13, 2015
Recall Status1 Terminated 3 on December 30, 2015
Recall Number Z-1437-2015
Recall Event ID 70821
510(K)Number K023113  K050258  K062566  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
Code Information Batch No. 13011562
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715/22725 Savi Ranch Pkwy
Yorba Linda CA 92887
For Additional Information Contact
714-282-4800
Manufacturer Reason
for Recall		 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to aeinfo@nobelbiocare.com. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.
Quantity in Commerce 2 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
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 = DZE and Original Applicant = NOBEL BIOCARE AB
510(K)s with Product Code = DZE and Original Applicant = NOBEL BIOCARE UAS INC
510(K)s with Product Code = DZE and Original Applicant = NOBEL BIOCARE USA LLC
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