AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
FDA device recall Z-0561-2013 · posted 2012-12-19 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- Reason for recall
- The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 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,
- Date initiated
- 2012-11-19
- Date posted
- 2012-12-19
- Date terminated
- 2013-09-24
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE AUTOTAC SYSTEM (K993493) | BioHorizons Implant Systems, Inc. | 2000-01-07 |