Z-1146-2012

Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is...

Name: Z-1146-2012 Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is...
Creator: Sybron Dental Specialties
Published: 2010-11-04
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2010-11-04 / Terminated / root cause: packaging

FDA source

Sybron Dental Specialties began a recall of Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material on 2010-11-04. The reason FDA records is "Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1146-2012
Status: Terminated
Initiated: 2010-11-04
Posted: 2012-03-02
Terminated: 2012-03-14
Recalling firm: Sybron Dental Specialties, Inc.
Product: Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.
Product code: ELW Material, Impression
Reason for recall: Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Pentron Clinical sent "Urgent Medical Device Recall" letters dated November 17, 2010 to consignees explaining the above mentioned public reason for recalls and asking them to determine if they have any of the affected products in their in stock. Product that is returned will be replaced at no charge. They also asked that they complete and fax back an enclosed recall return form. Questions can be directed to Customer Service at (800) 551-0283.
Quantity in commerce: 176 units
Distribution: Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.
Product codes and lots: Lot Number: 3510059

Product code ELW

K914178Class IICorrected-V.p.s.Jeneric/Pentron, Inc. / cleared 1992-04-28

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)