Recall Z-0592-2017 ยท NKB Thoracolumbosacral Pedicle Screw System
Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide tem
| Date | Nov 16, 2016 (initiated Oct 5, 2016) |
| Status | Terminated |
| Reason | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. |
| Root cause | Under Investigation by firm |
| Action | Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter. |
| Quantity | 16,972 units |
| Distribution | Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133221 | ARSENAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc., Mar 13, 2014 |