Device product
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Z-0205-2013
Product summary
- Firm
- Ormco/Sybronendo
- Event
- Event 63412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,543
- Official record key
device-enforcement:Z-0205-2013
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.