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SpineNet recalls SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usag
Recalled September 4, 2013 · FDA recall Z-2103-2013 · 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. · FDA Class II
Units
400
Sold at
USA Nationwide Distribution in the state of Florida
Description
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.
Product
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
Manufacturer(s)
SpineNet
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →