Events

Recall of Apex Pilot Shaft 13mm

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

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
    26157
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-04
  • Event Initiated Date
    2003-01-17
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27191
  • 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
    Reamer - Product Code HTO
  • Reason
    Pilot shaft may break during reaming or broaching of the femur.
  • Action
    Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design.

Device

Apex Pilot Shaft 13mm
  • Model / Serial
    Catalog Number: 690113 Lot NUmbers: 052, 113, 214
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CT, OH, FL, OK, TX, RI, NV, SC,
  • Product Description
    Apex Pilot Shaft 13mm
  • Manufacturer
    Apex Surgical, LLC

Manufacturer

Apex Surgical, LLC
  • Manufacturer Address
    Apex Surgical, LLC, 12 Harding Street, Suite 202, Lakeville MA 02347
  • Source
    USFDA