Events

Recall of Device Recall iLink Bone Void Filler

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
    52798
  • Event Risk Class
    Class 2
  • Event Number
    Z-1965-2009
  • Event Initiated Date
    2008-08-26
  • Event Date Posted
    2009-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84027
  • 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
    Failure to label the product properly. additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.
  • Action
    Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.

Device

Device Recall iLink Bone Void Filler
  • Model / Serial
    Model Number: 50-05-0010; Lot Number: A07D02B.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- TX.
  • Product Description
    iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
  • 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