[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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. |
|---|---|
| Brand / manufacturer | Ormco/Sybronendo |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0205-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 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.