Recall Z-2249-2017 ยท NKB Thoracolumbosacral Pedicle Screw System
Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product 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 tempo
| Date | May 5, 2017 |
| 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 | An Urgent Medical Device Recall notification letter dated 5/8/17 will be sent to customers to inform them that as a result of discussions with the FDA regarding a related recall of Arsenal Set Screw part number 47127, Alphatec Spine has made the decision to recall the original Arsenal Set Screw part number 47027. This action will remove all remaining pieces of part number 47027 from the domestic (U.S.) market and the Japan market. Arsenal set screw part number 47127 was recalled in September 2016. Arsenal set screw part number 4 7027 was not included in the recall because the complaints a |
| Quantity | 16,959 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133221 | ARSENAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc., Mar 13, 2014 |