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BioHorizons Implant Systems Inc recalls AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Recalled December 26, 2012 · FDA recall Z-0561-2013 · BioHorizons Implant Systems
Hazard
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. · FDA Class II
Units
174 units
Sold at
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.
Description
The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Product
AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
Manufacturer(s)
BioHorizons Implant Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →