| Class 2 Device Recall Neos Vanadium Excavator | |
Date Initiated by Firm | November 14, 2008 |
Date Posted | November 09, 2009 |
Recall Status1 |
Terminated 3 on August 09, 2012 |
Recall Number | Z-0151-2010 |
Recall Event ID |
50763 |
510(K)Number | K834055 |
Product Classification |
Excavator, Dental, Operative - Product Code EKC
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Product | Neos Vanadium Excavator Part Number 591/0 |
Code Information |
Batch Numbers: 3090952, 3059925, 3059926 |
Recalling Firm/ Manufacturer |
Sybron Dental Specialties 1717 W Collins Ave Orange CA 92867-5422
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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 | 135 |
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 |
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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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510(K) Database | 510(K)s with Product Code = EKC
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