Events

Recall of Device Recall RTI Biologics BioSet IC RT Paste 2 cc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RTI Surgical, 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
    76473
  • Event Risk Class
    Class 2
  • Event Number
    Z-1441-2017
  • Event Initiated Date
    2017-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153287
  • 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
    Incorrect instructions for use (ifu) included.
  • Action
    The firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product. If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: amcconnell@rtix.com.

Device

Device Recall RTI Biologics BioSet IC RT Paste 2 cc
  • Model / Serial
    Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution: Colombia only
  • Product Description
    RTI Biologics BioSet IC RT Paste 2 cc || Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
  • Manufacturer
    RTI Surgical, Inc.

Manufacturer

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