Events

Recall of Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.

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
    31822
  • Event Risk Class
    Class 3
  • Event Number
    Z-0918-05
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2005-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38572
  • 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
    Passer, Wire, Orthopedic - Product Code HXI
  • Reason
    The wire appears to be soft and the wire bent during insertion. this causes kinks in which the reamer could not pass over the bent/kinked wire.
  • Action
    The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.

Device

Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
  • Model / Serial
    Lot Numbers:  065882; 122235; 132557; 132560; 877265.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.
  • Product Description
    Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
  • Manufacturer
    EBI, L.P.

Manufacturer

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