Events

Recall of Device Recall 2.5mm Hex Driver

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
    28163
  • Event Risk Class
    Class 2
  • Event Number
    Z-0558-04
  • Event Initiated Date
    2004-01-14
  • Event Date Posted
    2004-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31301
  • 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 hex driver tips breaking off or becoming worn or stripped.
  • Action
    The only consignee was notified by letter on 1/14/2003.

Device

Device Recall 2.5mm Hex Driver
  • Model / Serial
    Catalog Number OP20004, Lot #04160301 Catalog Number SP00005-US, Lot # O2F108, O2F109, O2G322, O2G323, O2G324, O3E221.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    MN
  • Product Description
    2.5mm Hex Driver
  • Manufacturer
    U&I; America

Manufacturer

U&I; America
  • Manufacturer Address
    U&I; America, 6132 S 380 W Ste 200, Murray UT 84107-6988
  • Source
    USFDA