Ormco/Sybronendo: Medical Device Recall in 2012 - (Recall #: Z-0205-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 12, 2011

Date Posted: November 14, 2012

Recall Number: Z-0205-2013

Event ID: 63412

Reason for Recall:

The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.

Status: Terminated

Product Quantity: 4,543

Code Information:

Part Numbers 601-0007 and 601-0010, all lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated