FDAFDA · Food and drugs·Recall number Z-0357-2013
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Published November 28, 2012 · Recall initiated: January 5, 2009
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The tulip portion of the screw assembly can disengage from the shank after implantation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- NuVasive Inc
- Distributor
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- Lot
- Batch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States