Class II — Ebi, Llc
| Recalling firm | EBI, LLC - AHP EOS Buyer Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. |
| Product | Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. |
| Quantity | 1730 units |
| Distribution | Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI. |
| Initiated | 2013-04-09 |
| Classified | 2013-09-27 |
| Terminated | 2014-06-17 |
| Recall number | Z-2292-2013 |
| 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 — Ebi, Llc (Z-2292-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65043/
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