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Terminated

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

FDA Recall Z-0205-2013 · Posted 2012-11-05

Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeDZN
Date Initiated2011-12-12
Date Terminated2012-11-05
Product Quantity4,543

Reason for Recall

The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.

Firm 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.

Root Cause

Error in labeling

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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