Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
FDA Recall #Z-0205-2013 — Class II — December 12, 2011
Product Description
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
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.
Recalling Firm
Ormco/Sybronendo — Glendora, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Part Numbers 601-0007 and 601-0010, all lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated