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 body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. |
| Product | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental |
| Quantity | 119 units |
| Distribution | Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain. |
| Initiated | 2013-12-10 |
| Classified | 2014-02-20 |
| Terminated | 2014-03-28 |
| Recall number | Z-1058-2014 |
| 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-1058-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67090/
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