Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0205-2013 — Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.

U.S. FDA — Device Enforcement · United States · 2011-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0205-2013
Date of alert
2011-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ormco/Sybronendo
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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