Events

Rappel de Device Recall OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED

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 Exactech, 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
    61984
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2310-2012
  • Date de mise en oeuvre de l'événement
    2011-08-19
  • Date de publication de l'événement
    2012-09-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109647
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Exactech, inc. of gainesville, fl is recalling their optetrak logic posterior stabilized tibial insert, size 6 after the device was determined to be out of dimensional specification.
  • Action
    Exactech, Inc., sent an "IMPORTANT PRODUCT MARKET WITHDRAWAL NOTICE" letter dated August 19, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that are in possession of the products. 3. Verify if they had any of the affected products on the list. 4. Fax back the attached form. In addition, they were instructed to contact the Exactech inventory representative to confirm quantities at their location. If you have any questions regarding inventory restocking issue, please call -800-392-2832.

Device

Device Recall OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED
  • Modèle / numéro de série
    Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
  • Description du dispositif
    OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. || There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. || The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Adresse du fabricant
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Société-mère du fabricant (2017)
    Exactech Inc
  • Source
    USFDA