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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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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
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.

Product Detail

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