Events

Rappel de Device Recall Oto Flex Bur

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 Medtronic Xomed, 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
    25706
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0662-03
  • Date de mise en oeuvre de l'événement
    2002-01-25
  • Date de publication de l'événement
    2003-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26305
  • 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
    Bur, Ear, Nose And Throat - Product Code EQJ
  • Cause
    Product packaging pouches may be open thereby compomising the sterile barrier.
  • Action
    A recall notification letter and Effectiveness Response Form were Federal Expressed Overnight Delivery to the attention of the Risk Manager at each consignee on 1/25/2003. Consignees were requested to respond and return recalled product to Medtronic Xomed in Jacksonville, FL. or they can destroy them and request credit.

Device

Device Recall Oto Flex Bur
  • Modèle / numéro de série
    Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800 Part No. 31-55647, lot number 27123300
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine international accounts as follows (all distributors): 1- Kir-Op AS, Biskop Jens Nilssonsgt 5A, Postal Box 6631 Etterstad 0607 Oslo, Norway. 2- Kebo Care Dema, Jerholmen 41, DK 2650 Hvidovre Denmark 3- Biomedical Technology, Via Tolstoi 7, 20090 Trezzano Sul, Nabiglio, Milan Italy. 4-Apex Medical Est. Jawad Sikkarieh Bldg., Sweifeh Amman 111121, PO Box 213131 Jordan 5- Diseven, Carrera 12 No 102-07 Santafe de Bogota Colombia; 6- Wise Horse, 10F-1 No. 11, Minchuan, Taipei, Taiwan 7- Medtronic Xomed, Unit 2/446 Victoria Road, Gladesville NSW Australia 8- Medtronic Xomed France, Saint Aubin Le Monial, 03160 Bourbon L''Archambault France 9- Medtroni BV Earl Bakenstraat 10, 6422 P J Heerlen, PO BNox 25880 6401 Db Heerlen, The Netherlands
  • Description du dispositif
    Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: || Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; || Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; || Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; || Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur || PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr, N., Jacksonville FL 32216
  • Source
    USFDA