Recall Z-0205-2013— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2011-12-12, terminated 2012-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.. Reason: 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..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-12
- Terminated
- 2012-11-05
- Firm location
- Glendora, CA, United States
Product description
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.