Reported Nov 14, 2012 · Terminated
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Ormco/Sybronendo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339
Is this the product you have?
- Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
- Lot codes and dates
- Part Numbers 601-0007 and 601-0010, all lots
- Amount recalled
- 4,543
Where it was sold
- Nationwide
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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