Events

Rappel de Impaction fixture

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
    72229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0180-2016
  • Date de mise en oeuvre de l'événement
    2015-09-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140477
  • 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
    Impactor - Product Code HWA
  • Cause
    During the assembly, the impaction forces caused the polymer, black acetal copolymer from the impaction fixture to wear off on the lateral surface of the humeral stem titanium plasma spray coating.
  • Action
    DJO Global sent an Urgent Field Safety Notice dated September 15, 2015, to all affected consignees. The notice identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed become familiar with the new techniques and notify all of their applicable users of the RSP Monoblock and Turon stems of these revised methods. When each user has been notified of these new techniques, they should complete the form that was provided with the notification indicating that they have been informed of these changes and understand the new methods. Consignees were asked to complete and return forms. Consignees with questions should call 512-834-6255.

Device

Impaction fixture
  • Modèle / numéro de série
    Lot # 52748L02A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 || The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Adresse du fabricant
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Société-mère du fabricant (2017)
    The Blackstone Group LP
  • Source
    USFDA