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 temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
Recall
- Recall Number
- Z-2249-2017
- Event Number
- 77220
- Firm
- Alphatec Spine, Inc. 5830 El Camino Real
- FEI Number
- 2027467
- Product Code
- NKB
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 5, 2017
- Terminated
- June 6, 2017
- Address
- Carlsbad, CA, 92008-8816
Description
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 temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
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 associated with 47027 were within acceptable safety limits and remains so presently. Alphatec has received eight (8) complaints for disengagement of set screw 47027 since the product was introduced to the market on June 14, 2014, which equates to a disengagement failure rate for P/N 47027 of 0.095%. Customers are informed of the actions to be taken. Customers are instructed to fill out the last page of recall letter to confirm that you have read this notification and have taken all necessary actions as described in this notification.
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
16,959 units