Events

Recall of Device Recall Excella II Rod

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
    72878
  • Event Risk Class
    Class 2
  • Event Number
    Z-0662-2016
  • Event Initiated Date
    2015-12-07
  • Event Date Posted
    2016-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142397
  • 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
    Innovasis recalled two lots of excella ii titanium rods which were packaged using each other's labels.
  • Action
    Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.

Device

Device Recall Excella II Rod
  • Model / Serial
    Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in US -- CA; KS; OH; & TX.
  • Product Description
    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 || Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. || Intended for use in the non-cervical area of the spine.
  • 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