Events

Rappel de Device Recall Light Adaptor for SBD & SBD II

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
    74835
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2783-2016
  • Date de mise en oeuvre de l'événement
    2016-06-24
  • Date de publication de l'événement
    2016-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148562
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Cause
    There was a potential for the adaptor and light adaptor for small battery drive and small battery drive ii to generate excessive internal pressure that may cause the products to burst.
  • Action
    An Urgent Notice for this Recall was provided to the consignees on 6/24/2016. They were to review their inventory and return the products with instructions. IF YOU HAVE ANY PRODUCT: To immediately quarantine product so it's not used; ensure all in their facility read the Urgent Notice for the Recall; Call the DePuy Synthes Customer Support to obtain a Return Materials Authorization (RMA) Number; to complete the Verification Section indicating the product subject to recall was located; to return the Verification Section with the product to Product Returns, The Anspach Effort Inc., 4500 Riverside Drive, Palm Beach Gardens, FL 33410; Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Dept by: FAX (561) 627-2682 or Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com; Keep the notice visibly posted for awareness until all products have been returned; maintain a copy of the notice subject to this action and keep a copy for your records. The return documentation acknowledges your receipt of the medical device removal information. IF YOU DO NOT HAVE the identified product: complete the Verification Section of the recall, by checking the box indicating no affected product located; Include your name title, address, telephone #, signature and date; Send a copy of the completed Verification Section to DePuy Synthes Customer Quality Dept by: Fax: (561) 627-2682, or Scan/e-mail: DPYUS-PowerToolsFieldActions@its.jnj.com; This return document acknowledges your receipt of medical device removal information; ADVISORY: For Alternative products: This product does not have any inventory for replacement. Since the recall of this device may have an impact on your surgical schedule, DePuy Synthes Power Tools would like to propose alternative products to assist you with a replacement for the Recalled Adaptor (05.100.024) or Light Adaptor (05.001.108) . The products are the Small Battery Drive II Hand-piece (532.110) can also be operated

Device

Device Recall Light Adaptor for SBD & SBD II
  • Modèle / numéro de série
    Model/Catalog: Part # (05.001.108 and 05.001.024) Serial: All Serial Numbers.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.
  • Description du dispositif
    Light Adaptor for Small Battery Drive and Small Battery Drive II.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

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