FDA-Device2015-02-11Class II
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Medtronic Sofamor Danek USA Inc
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.
Sold states
Nationwide and Canada
Affected count
239 units
Manufactured in
1800 Pyramid Place, N/A, Memphis, TN, United States
Products
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2015Don't want to check this manually?
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