Events

Recall of Device Recall FormPutty Bone Void Filler 10cc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Theken Spine LLC.

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
    49018
  • Event Risk Class
    Class 3
  • Event Number
    Z-2375-2008
  • Event Initiated Date
    2008-07-11
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72528
  • 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
    Calcium Compound Bone Void Filler - Product Code MQV
  • Reason
    The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
  • Action
    In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.

Device

Device Recall FormPutty Bone Void Filler 10cc
  • Model / Serial
    Lot # A08F01E Exp Date 2010-06
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of FL, OH, TX, and UT.
  • Product Description
    FormPutty Bone Void Filler 10cc || The product is sealed in a foil pouch and then placed in a box following sterilization. || Part # 50-07-0100 || Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
  • Manufacturer
    Theken Spine LLC

Manufacturer

Theken Spine LLC
  • Manufacturer Address
    Theken Spine LLC, 1800 Triplett Blvd, Akron OH 44306-3311
  • Manufacturer Parent Company (2017)
    Theken Spine Llc
  • Source
    USFDA