Events

Recall of EBI Trochanteric 11mm Long Nail.

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

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
    32813
  • Event Risk Class
    Class 2
  • Event Number
    Z-0012-06
  • Event Initiated Date
    2005-06-24
  • Event Date Posted
    2005-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40870
  • 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
    Nail, Fixation, Bone - Product Code JDS
  • Reason
    Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
  • Action
    The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.

Device

EBI Trochanteric 11mm Long Nail.
  • Model / Serial
    Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
  • Product Description
    EBI Trochanteric 11mm Long Nail.
  • Manufacturer
    EBI, L.P.

Manufacturer

EBI, L.P.
  • Manufacturer Address
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA