Events

Recall of OsteoStim Cervical Allograft

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
    45502
  • Event Risk Class
    Class 3
  • Event Number
    Z-0825-2008
  • Event Initiated Date
    2007-10-23
  • Event Date Posted
    2008-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65659
  • 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
    Cervical Spacer - Product Code MQV
  • Reason
    Unapproved testing: tissue supplier (lifelink) utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the fda approved donor screening test. (note: tissue samples were later re-tested by an approved method and found non-reactive).
  • Action
    Urgent Recall Notice letters were mailed on October 23, 2007, requesting location of all product including sub-accounts and return for credit.

Device

OsteoStim Cervical Allograft
  • Model / Serial
    Catalog Number 45-5537;-Lot Numbers; 9677005006, 9677004606, 9677004906, 9677005206, 9677005306, 9677004406, 9677004506, 9677005506, 9677004706,, 9677005106, 9677004806, A0640037, A0630038, 9677005406, 9677005606, 967700416, and 9677004206; Catalog number LGAL906-Lot Number: 9346003406
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide to distributors/customers in NY, NC, MO, CA, FL and KS
  • Product Description
    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) || H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054
  • Manufacturer
    EBI, L.P.

Manufacturer

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