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Terminated

Neos Vanadium Excavator Part Number 591/0-6

FDA Recall Z-0155-2010 · Posted 2009-11-09

Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeEKC
Date Initiated2008-11-14
Date Terminated2012-08-09
Product Quantity18

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.

K834055VANADIUM EXCAVATORS SIZES 0-6Henry Schein, Inc. · 1984-02-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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