Events

Recall of Device Recall Polyaxial Pedicle Screw

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
    78946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0644-2018
  • Event Initiated Date
    2018-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160944
  • 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
    Thoracolumbosacral pedicle screw system - Product Code NKB
  • Reason
    Nine lots of 8.5 mm polyaxial pedicle screws are at risk of breakage.
  • Action
    The distributors were notified of the recall on 1/8/2018 via email with an attached pdf. They are also being asked to confirm or deny the quantities showing in inventory via a Product Removal Form sent in the same email.

Device

Device Recall Polyaxial Pedicle Screw
  • Model / Serial
    Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States
  • Product Description
    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral 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