Events

Recall of Device Recall Innovasis Excella II Standard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Innovasis, 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
    68781
  • Event Risk Class
    Class 2
  • Event Number
    Z-2067-2014
  • Event Initiated Date
    2014-07-07
  • Event Date Posted
    2014-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128657
  • 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 fixation - Product Code NKB
  • Reason
    Innovasis is recalling the excella ii standard pedicle screw due to mislabeling of the size and catalog number.
  • Action
    Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.

Device

Device Recall Innovasis Excella II Standard
  • Model / Serial
    E2S47525 Lot 1301 and E2S47535 Lot 1301
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
  • Product Description
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
  • Manufacturer
    Innovasis, Inc

Manufacturer

Innovasis, Inc
  • Manufacturer Address
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • Manufacturer Parent Company (2017)
    Innovasis, Inc.
  • Source
    USFDA