Recall Z-0151-2010 ยท EKC Excavator, Dental, Operative
Sybron Dental Specialties
Neos Vanadium Excavator Part Number 591/0
| Date | Nov 9, 2009 (initiated Nov 14, 2008) |
| Status | Terminated |
| Reason | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| Root cause | Component change control |
| Action | Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled "URGENT MEDICAL DEVICE RECALL," informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account. The consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address: KerrHawe SA Via Strecce 4 CH-6934 B |
| Quantity | 135 |
| Distribution | Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834055 | VANADIUM EXCAVATORS SIZES 0-6 Henry Schein, Inc., Feb 21, 1984 |