FDA-Device2013-09-04Class II
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
SpineNet
Hazard
The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.
Sold states
USA Nationwide Distribution in the state of Florida
Affected count
400
Manufactured in
1300 Minnesota Ave, Suite 200, Winter Park, FL, United States
Products
SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2013Don't want to check this manually?
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