Neos Vanadium Excavator Part Number 591/1
FDA Recall Z-0152-2010 · Posted 2009-11-09
Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeEKC
Date Initiated2008-11-14
Date Terminated2012-08-09
Product Quantity72
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.
Firm 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
Root Cause
Component change control
Distribution Pattern
Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.