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U.S. Department of Health and Human Services

Class 2 Device Recall Vector TAS Modular Driver

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 Class 2 Recall
Vector TAS Modular Driver
see related information
Date Posted November 05, 2012
Recall Status1 Terminated on November 05, 2012
Recall Number Z-0205-2013
Recall Event ID 63412
Product Classification Instruments, Dental Hand - Product Code DZN
Product Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Code Information Part Numbers 601-0007 and 601-0010, all lots
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora, California 91740-5339
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action "Urgent - Medical Device Correction" letters dated 12/12/2011 were sent via USPS 1st class mail to all customers and again on 2/21/2012 for recall expansion. The device issue was described and recommended actions were provided. Customers were instructed to acknowledge and complete the Return Form. Questions were referred to (800) 854-1741.
Quantity in Commerce 4,543
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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