Events

Rappel de MIKA Speedblock

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 Encore Medical, Lp.

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
    55605
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2164-2010
  • Date de mise en oeuvre de l'événement
    2010-04-26
  • Date de publication de l'événement
    2010-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91323
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 mika speedblocks.
  • Action
    An "Urgent Field Safety Notice" Letter dated May 20, 2010, was sent to the customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to locate, inspect and verify the quantity still in their possession, complete and return the field safety notice response page to Beth Onderlinde at beth.onderlinde@djosurgical.com or fax to 512-834-6313 by June 7, 2010, (completion of form is mandatory), and identify and inform customers that they may have distributed/sold product to, of the notice. The customer was also instructed to please inspect the listed part numbers prior to use and again after use, if a crack is found in the speedblock, contact your Customer Service Representative and be sure to utilize the femoral/tibial impactor (801-01-043) for impaction of the speedblock and reiterate to your physicians that the MIKA mini slaphammer (800-02-290) should be used for speedblock removal. The product will be replaced as it becomes available. If you have any questions, call Director of Commercial Logistics at (512) 834-6330 or International Customer Service at (512) 834-6275. You may also contact our EU Authorized Representative, MDSS GmbH, via email at info@mdss.com or via phone at +49 (0) 511 6262 8630.

Device

MIKA Speedblock
  • Modèle / numéro de série
    Model/Catalog Numbers: 800-01-368/370; 800-02-343/345; Specials that are affected: S1028, S1046, S1130, S1135, S1305, S1366, S1373, S1374, S1375, S1403, S1468, S1469, S1470, S1511, S1512, S1513
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    MIKA Speedblock, Size 8-12. || The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA