Events

Recall of OSTEOFIL DBM Paste, 5cc

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

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
    58887
  • Event Risk Class
    Class 2
  • Event Number
    Z-2634-2011
  • Event Initiated Date
    2011-04-09
  • Event Date Posted
    2011-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100476
  • 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
    Filler,bone void, calcium compound - Product Code MQV
  • Reason
    Rti biologics issued a recall of osteofil dbm paste, 5cc that was distributed on 03/04/2008 to one customer. the product was labeled as 5.0cc but should have been labeled as 0.5cc. all customers were notified of this recall on 04/09/2011.
  • Action
    RTI Biologics sent a "VOLUNTARY RECALL" letter dated April 9, 2008 to the one distributor, Spinal Graft Technologies. LLC. The letter describes the product, problem, and action to be taken by the distributor. The letter states that some of the product was issued a return authorization and requests that the distributor recover the remaining product from distribution. The recovered product will be issued a return authorization. RTI states the grafts can be returned in a non frozen state. Recall effectiveness will be determined by return of the product.

Device

OSTEOFIL DBM Paste, 5cc
  • Model / Serial
    4179877, 4179878, 4179693, 4179694, 4179695, 4179696, 4179697, 4179698, 4179699, 4179870, 4179872, 4179873, 4179874, 4179875, 4179416, 4179417, 4179418, 4179419, 4179690, 3217933, 4179410, 4179411, 4179412, 4179413, 4179414.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic Distribution--TN only.
  • Product Description
    ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID: 321933 Reorder: 002405 Lot #(Donor ID): 101050353 Expiration: 02/21/2013***STERILE***" || Bone Void Filler used in spinal surgery.
  • Manufacturer
    RTI Biologics, Inc.

Manufacturer

RTI Biologics, Inc.
  • Manufacturer Address
    RTI Biologics, Inc., 11621 Research Cir, Alachua FL 32615-6825
  • Manufacturer Parent Company (2017)
    RTI Surgical Inc
  • Source
    USFDA