FDAClass IINovember 14, 2012

Vector TAS Modular Driver recall

Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.

Why was Vector TAS Modular Driver recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Numbers 601-0007 and 601-0010, all lots

Product
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Recalling firm
Ormco/Sybronendo
Quantity
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.
Recall date
November 14, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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