FDA-Device2012-11-14Class II
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
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.
Sold states
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.
Affected count
4,543
Manufactured in
1332 S Lone Hill Ave, N/A, Glendora, CA, United States
Products
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2013Don't want to check this manually?
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