Neos Vanadium Excavator Part Number 591/0-6
FDA device recall Z-0155-2010 · posted 2009-11-09 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.
- Action taken
- 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 Bioggio Switzerland PLEASE LABEL RETURNED PRODUCT "RECALLED PRODUCT RETURN". In addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14
- Root cause
- Component change control
- Status
- Terminated
- Product code
- EKC
- Quantity affected
- 18
- Distribution
- Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.
- Date initiated
- 2008-11-14
- Date posted
- 2009-11-09
- Date terminated
- 2012-08-09
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANADIUM EXCAVATORS SIZES 0-6 (K834055) | Henry Schein, Inc. | 1984-02-21 |