Recall Z-0561-2013 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
| Date | Dec 19, 2012 (initiated Nov 19, 2012) |
| Status | Terminated |
| Reason | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. |
| Root cause | Component design/selection |
| Action | BioHorizons sent an "URGENT DEVICE CORRECTION" letter on November 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact the Customer Care Department at (888) 246-8338 for questions regarding this recall. |
| Quantity | 174 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Ecuador, Egypt, Fiji, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993493 | THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc., Jan 7, 2000 |