FDAFDA · Food and drugs·Recall number Z-0205-2013
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Published November 14, 2012 · Recall initiated: December 12, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ormco/Sybronendo
- Distributor
- 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.
- Lot
- Part Numbers 601-0007 and 601-0010, all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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