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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Recall Number Z-0205-2013
Classification Class II
Code Info Part Numbers 601-0007 and 601-0010, all lots
Product Distributed Qty 4,543
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.

Event Detail

Event Id 63412
Product Type Devices
Status Terminated
Recalling Firm Ormco/Sybronendo
City Glendora
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-12-12
Initial Firm Notification of Consignee or Public Letter
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.
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