Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
FDA device recall Z-0205-2013 · posted 2012-11-05 · Terminated
Recall details
- Recalling firm
- Ormco/Sybronendo
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DZN
- Quantity 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, Gre
- Date initiated
- 2011-12-12
- Date posted
- 2012-11-05
- Date terminated
- 2012-11-05
- Location
- Glendora, CA
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