Events

Rappel de Device Recall EXACTECH Equinoxe Narrow Modular Reverse PilotTip Starter Reamer

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
    77004
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2667-2017
  • Date de mise en oeuvre de l'événement
    2017-05-25
  • 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=154810
  • 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
    Rongeur - Product Code HTX
  • Cause
    Instructions for use (ifu) is updated to clarify the proper technique and instrumentation to ream the glenoid, i.E., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
  • Action
    On May 22, 2017 Exactech sent a Notification to all their Direct Accounts an Distributors telling them that a new updated technical techniques LIT # 718-01-30 Rev J is now available in their website (www.exac.com) or can be requested by contacting the Customer Service Representative at 800-392-2832, fax 352-378-2617 or via e-mail at Kaya@exac.com. This updated the technical techniques for implantation for Equinoxe Platform Shoulder System to clarify the proper technique for use of the Pilot Tip Reamers, i.e., to include caution statement that the surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head, as this may result in instrument breakage. The notification also request to forward and informed this notice to all the accounts that have received this product and to complete and return the attached Field Advisory Notice Respond Form within 5 days of receipt. For more information please contact: Kaya Davis, Inventory Representative at kaya@exac.com or by phone at (352) 377-1140

Device

Device Recall EXACTECH Equinoxe Narrow Modular Reverse PilotTip Starter Reamer
  • Modèle / numéro de série
    All Lots
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
  • Description du dispositif
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
  • 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