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 | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. |
| Product | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant |
| Quantity | 32 units |
| Distribution | Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran. |
| Initiated | 2015-10-30 |
| Classified | 2015-12-07 |
| Terminated | 2016-02-04 |
| Recall number | Z-0391-2016 |
| 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-0391-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72598/
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