Events

Recall of Device Recall UOC Femoral driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by United Orthopedic Corporation.

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
    76540
  • Event Risk Class
    Class 2
  • Event Number
    Z-1692-2017
  • Event Initiated Date
    2017-02-10
  • Event Date Posted
    2017-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153467
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
  • Action
    United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.

Device

Device Recall UOC Femoral driver
  • Model / Serial
    Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
  • Product Description
    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
  • Manufacturer
    United Orthopedic Corporation

Manufacturer

United Orthopedic Corporation
  • Manufacturer Address
    United Orthopedic Corporation, No. 57 Park Avenue 2, Science Park, Hsinchu Taiwan
  • Manufacturer Parent Company (2017)
    United Orthopedic Corp.
  • Source
    USFDA