FDA Device

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

Hazard

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.

What You Should Do

Remedy

"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.

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Products

Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Brand
Ormco/Sybronendo
UPC
Part Numbers 601-0007 and 601-0010, all lots

Units Affected

4,543

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