Recall Z-2103-2013— SpineNet
Class II · Terminated
Class II FDA medical device recall by SpineNet, initiated 2013-02-05, terminated 2014-05-02. It names one FDA 510(k) clearance: K110733. 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. Reason: 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..
- Recalling firm
- SpineNet
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-05
- Terminated
- 2014-05-02
- Firm location
- Winter Park, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.