Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Reported: November 14, 2012 Initiated: December 12, 2011 #Z-0205-2013
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.
Details
- Recalling Firm
- Ormco/Sybronendo
- Units Affected
- 4,543
- Distribution
- Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.
- Location
- Glendora, CA
Frequently Asked Questions
What product was recalled? ▼
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.. Recalled by Ormco/Sybronendo. Units affected: 4,543.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0205-2013.
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