Events

Rappel de Device Recall Jasper Vektor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par TP Orthodontics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79739
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1794-2018
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163888
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Spring, orthodontic - Product Code ECO
  • Cause
    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
  • Modèle / numéro de série
    25915000
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536R 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.
  • Adresse du fabricant
    TP Orthodontics, Inc., 100 Center Plz, La Porte IN 46350-9672
  • Société-mère du fabricant (2017)
    Tp Orthodontics, Inc.
  • Source
    USFDA