Events

Rappel de Device Recall Norian Drillable Injects Sterile

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 (USA) Products LLC.

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
    74172
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1942-2016
  • Date de mise en oeuvre de l'événement
    2016-05-11
  • Date de publication de l'événement
    2016-06-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146594
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Cause
    Depuy synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the norian drillable injects-sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
  • Action
    DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and 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 by:Fax: 855-695-8597 or Scan/email: Synthes6797@stericycle.com. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.

Device

Device Recall Norian Drillable Injects Sterile
  • Modèle / numéro de série
    Catalog ID 07.704.003S, 07.704.005S and 07.704.010S Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013, DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...
  • Description du dispositif
    Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S || Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA