Recall Z-1421-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
Alphatec Spine, Inc.
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
| Date | May 28, 2013 (initiated May 6, 2013) |
| Status | Terminated |
| Reason | Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve |
| Root cause | Device Design |
| Action | Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 1,814 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113366 | LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM Phygen, LLC, Jan 17, 2012 |