Home / Recalls / Ormco/Sybronendo / Z-0205-2013

Z-0205-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
December 12, 2011
Termination Date
November 5, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,543

Product Description

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

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.

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.

Code Information

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

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  • Z-2194-2013 Class II — Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Ve (July 12, 2013)