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U.S. Department of Health and Human Services

Class 2 Device Recall Abutment Retrieval Instrument

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  Class 2 Device Recall Abutment Retrieval Instrument see related information
Date Initiated by Firm June 22, 2015
Date Posted July 15, 2015
Recall Status1 Terminated 3 on September 18, 2015
Recall Number Z-2074-2015
Recall Event ID 71552
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
Code Information Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.
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		 One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
FDA Determined
Cause 2		 Under Investigation by firm
Action A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.
Quantity in Commerce 149 units total
Distribution Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
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.
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