Z-0205-2013Class II

Vector TAS Modular Driver, a manual driver for Vector TAS dental screws

Name: Z-0205-2013 Vector TAS Modular Driver, a manual driver for Vector TAS dental screws
Creator: Ormco/Sybronendo
Published: 2011-12-12
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2011-12-12 / Terminated / root cause: labeling and UDI

FDA source

Ormco/Sybronendo began a recall of Vector TAS Modular Driver, a manual driver for Vector TAS dental screws on 2011-12-12. FDA classified it as Class II and gives the reason as "The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0205-2013
Classification: Class II
Status: Terminated
Initiated: 2011-12-12
Posted: 2012-11-05
Terminated: 2012-11-05
Recalling firm: Ormco/Sybronendo
Product: Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Product code: DZN Instruments, Dental Hand
Reason for recall: The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: "Urgent - Medical Device Correction" letters dated 12/12/2011 were sent via USPS 1st class mail to all customers and again on 2/21/2012 for recall expansion. The device issue was described and recommended actions were provided. Customers were instructed to acknowledge and complete the Return Form. Questions were referred to (800) 854-1741.
Quantity in commerce: 4,543
Distribution: Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.
Product codes and lots: Part Numbers 601-0007 and 601-0010, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0205-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0205-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

Product code DZN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)