Class II — BioHorizons Implant Systems Inc
| Recalling firm | BIOHORIZONS IMPLANT SYSTEMS, INC. |
|---|---|
| Registered facility | BIOHORIZONS IMPLANT SYSTEMS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. |
| Product | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. |
| Quantity | 1246 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 Ar… |
| Initiated | 2012-11-19 |
| Classified | 2012-12-19 |
| Terminated | 2013-09-24 |
| Recall number | Z-0562-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BioHorizons Implant Systems Inc (Z-0562-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63744/
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