Recall Z-0205-2013 ยท DZN Instruments, Dental Hand
Ormco/Sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
| Date | Nov 5, 2012 (initiated Dec 12, 2011) |
| Status | Terminated |
| 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, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.