Class II — NuVasive Inc
| Recalling firm | NUVASIVE, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Product | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI |
| Quantity | 240 units total |
| Distribution | Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. |
| Initiated | 2009-01-05 |
| Classified | 2012-11-19 |
| Terminated | 2012-11-19 |
| Recall number | Z-0371-2013 |
| 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 — NuVasive Inc (Z-0371-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/52634/
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