Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
This recall has been terminated (originally issued November 5, 2012).
- Company
- Ormco/Sybronendo
- Recall Initiated
- December 12, 2011
- Posted
- November 5, 2012
- Terminated
- November 5, 2012
- Recall Number
- Z-0205-2013
- Quantity
- 4,543
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.
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.
Lot / Code Info
Part Numbers 601-0007 and 601-0010, all lots
Root Cause
Error in labeling
Action Taken
"Urgent - Medical Device Correction" letters dated 12/12/2011 were sent via USPS 1st class mail to all customers and again on 2/21/2012 for recall expansion. The device issue was described and recommended actions were provided. Customers were instructed to acknowledge and complete the Return Form. Questions were referred to (800) 854-1741.