FDA-Device2015-01-21Class II
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
SpineFrontier, Inc.
Hazard
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
Sold states
Nationwide Distribution including TX, OH, VA, and Washington, DC.
Affected count
4 devices
Manufactured in
500 Cummings Ctr Ste 3500, Beverly, MA, United States
Products
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2015Don't want to check this manually?
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