FDA-Device2015-01-21Class II
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Medtronic Sofamor Danek USA Inc
Hazard
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Sold states
US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
Affected count
24 units
Manufactured in
1800 Pyramid Place, Memphis, TN, United States
Products
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2015Don't want to check this manually?
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