Events

Recall of Polyaxial screwdriver.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by U&I; America.

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
    27014
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-03
  • Event Initiated Date
    2003-08-18
  • Event Date Posted
    2003-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29031
  • 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 - Product Code MNI
  • Reason
    Reports of pieces chipping off the tip of screwdriver during use.
  • Action
    Consignee was notified by letter on 8/18/2003

Device

Polyaxial screwdriver.
  • Model / Serial
    Part Number OP20012 Revision B, Lot Numbers 04240301 and 04140302.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    MN
  • Product Description
    Optima Large Poly Screw Driver
  • Manufacturer
    U&I; America

Manufacturer

U&I; America
  • Manufacturer Address
    U&I; America, 6132 South 380 West - Suite 200, Murray UT 840434355
  • Source
    USFDA