Events

Rappel de Device Recall Cannulated Drill Bits

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 Synthes, 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
    71277
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1711-2015
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • Date de publication de l'événement
    2015-06-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137214
  • 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
    Bit, drill - Product Code HTW
  • Cause
    Affected parts and lots of the cannulated drill bits have the potential to break during use.
  • Action
    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the identified devices, please take the following steps: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " 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. " Return the Verification Section (page 3 of this letter) with the product to: " Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. " Send a copy of the completed Verification Section to DePuy Synthes by: " Fax: (888) 943-4893 or " Scan/email: Synthes6230@stericycle.com If you DO NOT have the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) 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 removal information. " Return the documents to DePuy Synthes by: " Fax: (888) 943-4893 or " Scan/email: Synthes6230@stericycle.com " Note: If the Verification Section is answered on behalf of more th An urgent medical device recall notice, dated May 13, 2015, was sent to consignees and sales consultants to in form them of the issue and associated risks. All in receipt of the device were asked to discontinue use and return affected devices along with the response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales

Device

Device Recall Cannulated Drill Bits
  • Modèle / numéro de série
    Part Number  310.65 310.67 310.221  lot numbers  PE00966  PE01000 PE01039 PE01058 PE00959  PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971  PE01059 PE01040
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Description du dispositif
    3.2 mm Cannulated Drill Bit/ QC 170 mm || 2.7 Cannulated Drill Bit/ QC 160 mm || 2.0 mm Cannulated Drill Bit / QC 150 mm || there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Adresse du fabricant
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA