FDA-Device2018-01-24Class II
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Medtronic Sofamor Danek USA Inc
Hazard
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Sold states
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Affected count
3,319 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2018Don't want to check this manually?
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