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[Recalled] Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. — The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign… | FDA 2011-12-12

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductVector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Brand / manufacturerOrmco/Sybronendo
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0205-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date12 December 2011

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Ormco/Sybronendo

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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