Events

Recall of Arsenal Spinal Fixation System, Set Screw, Part No. 47127

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alphatec Spine, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75337
  • Event Risk Class
    Class 2
  • Event Number
    Z-0592-2017
  • Event Initiated Date
    2016-10-05
  • Event Date Posted
    2016-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150094
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • 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.
  • 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.

Device

Arsenal Spinal Fixation System, Set Screw, Part No. 47127
  • Model / Serial
    Lot Numbers 695621  696252  697128  698437  700943  7689801 695622  696253  697129  698438  700944  7689802 695623  696254  697130  698439  700945  7689803 695624  696255  697131  698440  701393  7689804 695625  696256  697520  698441  701394  695626  696257  697521  698442  701395  695627  696258  697522  700611  701396  696124  696558  697523  700612  701397  696125  696574  697524  700613  701398 696126  696575  698433  700614  701399 696127  696576  698434  700615  701400 696128  696577  698435  700941  701401 696251  697127  698436  700942  701851 7878901 7829602 7766302 7766301
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.
  • Product Description
    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 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 ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Manufacturer Address
    Alphatec Spine, Inc., 5830 El Camino Real, Carlsbad CA 92008-8816
  • Manufacturer Parent Company (2017)
    Alphatec Spine Inc
  • Source
    USFDA