Events

Rappel de Device Recall Hydroset

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 Stryker Craniomaxillofacial Division.

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
    65787
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2054-2013
  • Date de mise en oeuvre de l'événement
    2013-07-30
  • Date de publication de l'événement
    2013-08-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120159
  • 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
    Methyl methacrylate for cranioplasty - Product Code GXP
  • Cause
    Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. this could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.
  • Action
    Stryker sent an Urgent Medical Device Recall Notices with attached Product Correction Bulletin dated, July 30, 2013, describing the product, problem and possible adverse events associated with the recall were sent to all affected customers. Customers were instructed to pass the notice and bulletin to all individuals who may be using the device, provided instructions on procedures which would help mitigate risk and return the customer response form to our Customer Service Team by email, fax or letter. Email: CMF-custserv@stryker.com Fax: 1-877-648-7114 Address: 750 Trade Centre Way, Suite 200 Portage, MI 49002 Customers responses will be tracked and non-responders will be contacted. Further questions please call (877) 534-2464.

Device

Device Recall Hydroset
  • Modèle / numéro de série
    Part 79-43903, Lot: IC01116, IC01130, IC01204, IC01233, IC01238 Part 79-43905 Lot: IC01084, IC01085, IC01086, IC01093, IC01123, IC01150, IC01166, IC01167, IC01168, IC01180, IC01188, IC01189, IC01190, IC01198, IC01199, IC01200, IC01213, IC01214, IC01229, IC01230, IC01239, IC01240, IC01245, IC01246, IC01270 Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154, IC01163, IC01164, IC01165, IC01179, IC01183, IC01184, IC01201, IC01202, IC01203, IC01231, IC01243, IC01244, IC01248, IC01249, IC01261, IC01264,   Part 79-43015 Lot: IC01100, IC01114, IC01161, IC01162, IC01182, IC01211, IC01212, IC01227, IC01228, IC01241, IC01242, IC01252, IC01253, IC01254, IC01267  Part 397003 Lot: IC01092, IC01101, IC01102, IC01103, IC01104, IC01105, IC01106, IC01107, IC01115, IC01127, IC01131, IC01205, IC01220, IC01232, IC01234  Part 397005 Lot: IC01088, IC01094, IC01095, IC01096, IC01097, IC01098, IC01110, IC01111, IC01118, IC01119, IC01120, IC01132, IC01133, IC01134, IC01135, IC01136, IC01137, IC01147, IC01148, IC01149, IC01158, IC01159, IC01160, IC01171, IC01172, IC01181, IC01193, IC01194, IC01195, IC01196, IC01223, IC01224, IC01247Part 79-43910 Lot: IC01087, IC01090, IC01091, IC01153, IC01154  Part 397010 Lot: IC01099, IC01108, IC01109, IC01112, IC01121, IC01138, IC01139, IC01140, IC01141, IC01151, IC01152, IC01155, IC01156, IC01157, IC01173, IC01174, IC01191, IC01192, IC01197, IC01210, IC01216, IC01219, IC01225, IC01226, IC01250, IC01251, IC01263, IC01266, IC01301  Part 397015 Lot: IC01113, IC01122, IC01124, IC01125, IC01142, IC01143, IC01144, IC01145, IC01146, IC01169, IC01170, IC01177, IC01178, IC01185, IC01186, IC01187, IC01206, IC01207, IC01208, IC01209, IC01217, IC01218, IC01221, IC01222, IC01265
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries through Stryker Distribution: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, Argentina, Australia, Brazil, Jordan, Kingdom of Saudi Arabia, Kuwait, Latin America (others), New Zealand, Russia, Singapore, South Africa, and United Arabian Emirates.
  • Description du dispositif
    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland || Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The powder is mixed with the sodium phosphate/PVP solution provided in the kit and loaded into the empty cement delivery syringe to be applied directly to the site for void filling or augmentation.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Adresse du fabricant
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way, Ste 200, Portage MI 49002-0482
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA