7 — Class II medical device recall Z-0378-2013
Terminated recall by NuVasive Inc, reported 2012-11-28, distributed nationwide. The tulip portion of the screw assembly can disengage from the shank after implantation.
| Recall number | Z-0378-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Inc, San Diego, CA, United States |
| Recall initiated | 2009-01-05 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2012-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 240 units |
| Lot numbers | JK2041, JK2146, JK2396, JK2397 |
Product
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Reason for recall
The tulip portion of the screw assembly can disengage from the shank after implantation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0378-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.