FDA Device recall Z-0356-2013
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI by Nuvasive, citing the tulip portion of the screw assembly can disengage from the shank after implantation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0356-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2009-01-05 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nuvasive |
| Distribution | US |
Product
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Reason
The tulip portion of the screw assembly can disengage from the shank after implantation.
Identifiers
| code_info | Batch: JK2083, JK2184 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0356-2013%22
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