FDAFDA · Food and drugs·Recall number Z-1057-2015
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Published February 11, 2015 · Recall initiated: January 13, 2015
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 product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- Nationwide and Canada
- Lot
- WI14H054
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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