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

Z-0205-2013 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

FDA device recall Z-0205-2013 was initiated by Ormco/Sybronendo on December 12, 2011 and is designated Class II. 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 … The recall status is terminated (terminated November 5, 2012). Affected quantity: 4,543.

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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