Events

Recall of Device Recall Jasper Vektor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TP Orthodontics, 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
    79739
  • Event Risk Class
    Class 2
  • Event Number
    Z-1793-2018
  • Event Initiated Date
    2018-05-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163887
  • 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
    Spring, orthodontic - Product Code ECO
  • Reason
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Action
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com

Device

Device Recall Jasper Vektor
  • Model / Serial
    17515000, 17615000, 25915000
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.
  • Product Description
    Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
  • Manufacturer
    TP Orthodontics, Inc.

Manufacturer

TP Orthodontics, Inc.
  • Manufacturer Address
    TP Orthodontics, Inc., 100 Center Plz, La Porte IN 46350-9672
  • Manufacturer Parent Company (2017)
    Tp Orthodontics, Inc.
  • Source
    USFDA