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Ormco/Sybronendo recalls Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Recalled November 14, 2012 · FDA recall Z-0205-2013 · Ormco/Sybronendo
Hazard
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. · FDA Class II
Units
4,543
Sold at
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.
Description
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.
Product
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Manufacturer(s)
Ormco/Sybronendo
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →