FDA Medical Device Recalls (openFDA)
Ormco/Sybronendo: Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
- Recall number
- Z-0205-2013
- Recalling firm
- Ormco/Sybronendo
- Product
- Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
- Status
- Terminated
- Initiated
- 2011-12-12
- Posted
- 2012-11-05
- Terminated
- 2012-11-05
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- "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.
- Quantity
- 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.
- Lot, serial or model codes
- Part Numbers 601-0007 and 601-0010, all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZN
- Firm FEI
- 2016150
- Firm city
- Glendora
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28