Z-0561-2013Class II

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental

Name: Z-0561-2013 AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental
Creator: BioHorizons Implant Systems Inc
Published: 2012-11-19
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2012-11-19 / Terminated / root cause: design

FDA source

BioHorizons Implant Systems Inc began a recall of AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental on 2012-11-19. FDA classified it as Class II and gives the reason as "The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0561-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-19
Posted: 2012-12-19
Terminated: 2013-09-24
Recalling firm: BioHorizons Implant Systems Inc
Product: AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Root cause tag: design
FDA 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 in commerce: 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, Lithuania, Malaysia, Mexico, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Lot Numbers: 02070051, 04070030, 0800152, 06070018, 0801863, 0802225, 0802469, 0900838, 0901751, 0902145, 0902956, 1000003, 1001504, 1004620, 1101301, 1101802, 1103359, 1104032, 1104976, 1200616, and 1202282

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0561-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19
Z-0562-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code DZE

K993493Class IIThe Autotac SystemBioHorizons Implant Systems, Inc. / cleared 2000-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)