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Medtronic Sofamor Danek USA Inc recalls KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use wit
Recalled February 11, 2015 · FDA recall Z-1057-2015 · Medtronic Sofamor Danek USA
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. · FDA Class II
Units
239 units
Sold at
Nationwide and Canada
Description
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.
Product
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Manufacturer(s)
Medtronic Sofamor Danek USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →