Medtronic Sofamor Danek USA Inc recalls Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
- Recall date
- December 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0352-2018
- FDA classification
- Class II
- Brand / firm
- Medtronic Sofamor Danek USA Inc
- Sold / distributed
- US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
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