Recall Z-0575-2014 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SpineFrontier, Inc.
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
| Date | Dec 26, 2013 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | Mismarked and unmarked screws |
| Root cause | Packaging process control |
| Action | On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email. |
| Distribution | Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM Spinefrontier, Inc., Jul 3, 2012 |