Ormco Vector TAS Modular Driver Recalled for Incorrect Sterilization Instructions
Ormco/Sybronendo is recalling Vector TAS Modular Drivers because foreign language instructions list the wrong sterilization temperature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error regarding sterilization temperature in foreign language sections, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling issues without reported injuries.
Plain-English summary
Ormco/Sybronendo is recalling 4,543 units of the Vector TAS Modular Driver, a manual driver used for Vector TAS dental screws. The recall affects Part Numbers 601-0007 and 601-0010 across all lots.
The recall was initiated because the Instructions For Use (IFUs) for certain foreign language sections incorrectly list the sterilization temperature as 130°C. The correct sterilization temperature is 132°C and/or 270°F. This labeling error could potentially lead to improper sterilization of the device.
The affected products were distributed worldwide, including in the United States, Canada, and numerous countries in Europe and other regions. Users should stop using the affected drivers and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
- Manufacturer
- Ormco/Sybronendo
- Affected units
- 4,543
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Numbers 601-0007 and 601-0010
- all lots
Distribution
Distributed nationwide across the United States.
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