Events

Rappel de Device Recall Anspach Single Use, Sterile Bone Cutting Burrs

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 The Anspach Effort, 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
    59837
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0102-2012
  • Date de mise en oeuvre de l'événement
    2008-05-19
  • Date de publication de l'événement
    2011-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104176
  • 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
    Burr, orthopedic - Product Code HTT
  • Cause
    The anspach effort, inc. initiated a recall on may 6, 2008 for their sterile bone cutting burrs. all affected customers were notified of the recall by letter dated 5/29/2008.
  • Action
    The firm, Anspach sent an "URGENT PRODUCT REMOVAL" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached "Product Replacement Form." Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the "Product Replacement Form" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the "Product Replacement Form." 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed "Product Replacement Form." Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.

Device

Device Recall Anspach Single Use, Sterile Bone Cutting Burrs
  • Modèle / numéro de série
    Lot number: B083004742.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, CO, FL, GA, IA, ID, SC, MA, MD, MI, MO, MN, MS, NY, OH, OR, PA, TN, TX, and WI, and the countries of: Africa, Netherlands, Panama, South Korea, Spain, and United Kingdom.
  • Description du dispositif
    "***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***" || Lot number: B083004742. || Product Usage: Cutting and shaping bone including bones of the spine and cranium.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Adresse du fabricant
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA