Class II — SpineNet
| Recalling firm | SpineNet |
|---|---|
| Registered facility | SpineNet LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing. |
| Product | SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level |
| Quantity | 400 |
| Distribution | USA Nationwide Distribution in the state of Florida |
| Initiated | 2013-02-05 |
| Classified | 2013-08-27 |
| Terminated | 2014-05-02 |
| Recall number | Z-2103-2013 |
| 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 — SpineNet (Z-2103-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65917/
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