Events

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

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
    59182
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3202-2011
  • Date de mise en oeuvre de l'événement
    2011-03-17
  • Date de publication de l'événement
    2011-09-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101557
  • 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
    Motor, drill, electric - Product Code HBC
  • Cause
    The anspach effort, palm beach gardens, fl, is recalling their single use, sterile bone cutting burrs, catalog #, s-1504td, lot #s d363039140. d323038110, d293037349 and catalog # turq-434-4, lot #s d343038845, d323038131, due to the burr being 2.0 mm longer than stated on the label. as a result, a hole drilled using this burr would be 2 mm deeper than the screw.
  • Action
    Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.

Device

Device Recall Anspach Single Use, Sterile Bone Cutting Burs
  • Modèle / numéro de série
    Lot #s, D363039140, D323038110, D293037349
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
  • Description du dispositif
    Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***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: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***". || 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