Events

Rappel de Anspach Cutters and Attachments

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
    67124
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0708-2014
  • Date de mise en oeuvre de l'événement
    2012-10-26
  • Date de publication de l'événement
    2014-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124743
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Cause
    During a recent review of documentation anspach determined that the current directions for use for the mca cutting burrs and mca micro curved attachment do not provide clear details regarding the intended use specifically for the mca burrs. the mca burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. the use of the device in dense bone removal may result in cu.
  • Action
    Anspach sent an Urgent Medical Removal letter dated October 26, 2012, to all affected customers. The letter stated that they were initiating a Medical Device removal regarding the MCA Cutting Burrs. During a recent review of documentation it was determined that the current directions for use for the MCA cutting burrs (item 18-0079) and MCA Micro Curved Attachment (item 18-0060) did not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cutter/ burr fracture. If a fracture occurs, contact Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. If the procedure was done successfully, no additional patient follow up is necessary. Customer Immediate Actions: 1. Please remove and return any MCA items from your inventory immediately. 2. Complete the attached reply form indicating your receipt of this letter. Return the completed form by fax or email to the number or email address provided on the form. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Customers with questions were instructed to contact Anspach Customer Support at (800) 327-6887 or email ProductSupportTeam@synthes.com. For questions regarding this recall call 1-800-327-6887.

Device

Anspach Cutters and Attachments
  • Modèle / numéro de série
    All Lots for  MCA - MICRO CURVED ATTACHMENT,  MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,  MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,  MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,  MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,  MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,  MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,  MCA5-1SB - lMM FLUTED BALL, 5.6CM,  MCA5-1SD - lMM DIAMOND BALL, 5.6CM,  MCA5-2SB - 2MM FLUTED BALL, 5.6CM,  MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,  MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,  MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,  MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,  MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,  MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,  MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,  MCA7-1SB - lMM FLUTED BALL, 7.3CM,  MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM,  MCA7-2SB - 2MM FLUTED BALL, 7.3CM and  MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
  • Description du dispositif
    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) || MCA - MICRO CURVED ATTACHMENT, || MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, || MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, || MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, || MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, || MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, || MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, || MCA5-1SB - lMM FLUTED BALL, 5.6CM, || MCA5-1SD - lMM DIAMOND BALL, 5.6CM, || MCA5-2SB - 2MM FLUTED BALL, 5.6CM, || MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, || MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, || MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, || MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, || MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, || MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, || MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, || MCA7-1SB - lMM FLUTED BALL, 7.3CM, || MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, || MCA7-2SB - 2MM FLUTED BALL, 7.3CM and || MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. || The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
  • 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