Events

Recall of Device Recall Atlas Spine Torque Limiting Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Atlas 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
    73657
  • Event Risk Class
    Class 2
  • Event Number
    Z-1616-2016
  • Event Initiated Date
    2013-07-26
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144672
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • Reason
    The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
  • Action
    Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102.

Device

Device Recall Atlas Spine Torque Limiting Handle
  • Model / Serial
    Lots #: 8887, 000073, 000135, 00434, and 02518.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to FL, MO, and WV.
  • Product Description
    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 || Used to rotate implant into position
  • Manufacturer
    Atlas Spine, Inc.

Manufacturer

Atlas Spine, Inc.
  • Manufacturer Address
    Atlas Spine, Inc., 1555 Jupiter Park Dr Ste 4, Jupiter FL 33458-8085
  • Manufacturer Parent Company (2017)
    Atlas Spine Inc.
  • Source
    USFDA