Events

Rappel de Device Recall OCM Cutting Burrs (Cutters)

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
    73738
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1668-2016
  • Date de mise en oeuvre de l'événement
    2016-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144999
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Cause
    Certain lots of the otologic curved micro (ocm) diamond ball burrs may be missing the diamond coating and the ball may be the incorrect size.
  • Action
    Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to RA-DPYUS-chu.pb@ITS.JNJ.com. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. ¿ Return the documents to The Anspach Effort by: ¿ Fax: (561) 627-2682 ¿ Scan/email: RA-DPYUS-chu.pb@ITS.JNJ.com ¿ Giving them to your DePuy Synthes Sales Consultant ¿ Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.

Device

Device Recall OCM Cutting Burrs (Cutters)
  • Modèle / numéro de série
    Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in the states of KY and TX.
  • Description du dispositif
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • 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