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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 NPsee related information
Date Initiated by FirmMarch 09, 2015
Date PostedApril 13, 2015
Recall Status1 Terminated 3 on December 30, 2015
Recall NumberZ-1414-2015
Recall Event ID 70821
510(K)NumberK023113 K050258 K062566 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductReplace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Code Information Batch No. 13011366, 13011446, 13011544.
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
ActionNobel 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 Commerce131 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = DZE
510(K)s with Product Code = DZE
510(K)s with Product Code = DZE
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