Recall Z-2103-2013 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
SpineNet
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
| Date | Aug 27, 2013 (initiated Feb 5, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | SpineNET sent a Customer Notification letter dated 02/05/2013 to their only customer (Halifax Medical Center). The letter identified the affected product, problem and actions to be taken. Customers were informed to remove any copies of the original IFU-ACC-01 form from their records and replace with the IFU-ACC-02 form attached to the letter. For questions contact SpineNET office directly. |
| Quantity | 400 |
| Distribution | USA Nationwide Distribution in the state of Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110733 | DAYTONA ANTERIOR CERVICAL CAGE Spinenet, LLC, Aug 25, 2011 |