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U.S. Department of Health and Human Services

Class 2 Device Recall Neos Vanadium Excavator

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  Class 2 Device Recall Neos Vanadium Excavator see related information
Date Initiated by Firm November 14, 2008
Date Posted November 09, 2009
Recall Status1 Terminated 3 on August 09, 2012
Recall Number Z-0157-2010
Recall Event ID 50763
510(K)Number K834055  
Product Classification Excavator, Dental, Operative - Product Code EKC
Product Neos Vanadium Excavator Part Number 591/3 SCHE
Code Information Batch Numbers: 3105357
Recalling Firm/
Manufacturer		 Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall		 The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
FDA Determined
Cause 2		 Component change control
Action Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14
Quantity in Commerce 10
Distribution Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
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 = EKC and Original Applicant = HENRY SCHEIN, INC.
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