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 | BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium. |
| Product | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement |
| Quantity | 48 units |
| Distribution | US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC. |
| Initiated | 2015-04-16 |
| Classified | 2015-05-12 |
| Terminated | 2015-08-07 |
| Recall number | Z-1605-2015 |
| 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-1605-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71125/
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