Z-0157-2010

Neos Vanadium Excavator Part Number 591/3 SCHE

Name: Z-0157-2010 Neos Vanadium Excavator Part Number 591/3 SCHE
Creator: Sybron Dental Specialties
Published: 2008-11-14
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2008-11-14 / Terminated

FDA source

Sybron Dental Specialties began a recall of Neos Vanadium Excavator Part Number 591/3 SCHE on 2008-11-14. The reason FDA records is "The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0157-2010
Status: Terminated
Initiated: 2008-11-14
Posted: 2009-11-09
Terminated: 2012-08-09
Recalling firm: Sybron Dental Specialties, Inc.
Product: Neos Vanadium Excavator Part Number 591/3 SCHE
Product code: EKC Excavator, Dental, Operative
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 root cause: 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.
Product codes and lots: Batch Numbers: 3105357

Product code EKC

K834055Class IVanadium Excavators Sizes 0-6Henry Schein, Inc. / cleared 1984-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)