Events

Rappel de Device Recall Stryker Neptune 3 Rover

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 Instruments Div. of Stryker Corporation.

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
    74759
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2630-2016
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • Date de publication de l'événement
    2016-08-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148396
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Cause
    Stryker initiated a voluntary recall of the 120 v neptune 3 rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.
  • Action
    Stryker Instruments initiated a voluntary recall of the Stryker Neptune 3 Rover via certified mail on 07/01/2016, due to the potential for the Neptune 3 Rover to experience system errors if there are high levels of electromagnetic interference in the operating room. 1. Immediately review the Recall Notification. 2. Confirm that the Rover serial numbers identified on the Business Reply Form (BRF) are at your facility. 3. A Stryker representative will facilitate the repair of your affected Neptune 3 Rover(s). Please coordinate the availability of the product to assure the repair can be implemented. 4. Please complete and return the Business Reply Form (BRF). Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 5. Fax the completed, signed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. 6. Stryker will document the repair of each unit by serial number. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis 269-389-2921 kellyjo.davis@stryker.com

Device

Device Recall Stryker Neptune 3 Rover
  • Modèle / numéro de série
    120 V Neptune 3 Rover, Model Number: 0703-001-000; Serial Numbers: 1606300523, 1610606263, 1610903973, 1610904293, 1612303683, 1612303823, 1612303963, 1606300553, 1610606273, 1610904063, 1610904313, 1612303703, 1612303833, 1612303973, 1606300583, 1610606303, 1610904083 , 1610904343, 1612303713, 1612303843 , 1612303993, 1606300593, 1610606323, 1610904103, 1610904353, 1612303723, 1612303853 , 1613106443, 1606300613, 1610606353, 1610904123, 1610904363 , 1612303733, 1612303863, 1613106463, 1606300623, 1610619473, 1610904163, 1610904373 , 1612303743, 1612303873, 1613106583, 1606300643, 1610619483, 1610904173, 1610904403, 1612303763 , 1612303883 , 1613201233, 1606300653, 1610619543, 1610904183, 1612303633, 1612303783, 1612303903, 1613201243 , 1607503463 , 1610619573 , 1610904193, 1612303643, 1612303793, 1612303913, 1613201303,  1607503493, 1610619603 , 1610904203, 1612303663, 1612303813, 612303933, 1613201323, 1610409473, 1610903893, 1610904213, 1612303673
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Domestic:MI, CA, ID, IA VA/DOD: None Foreign: None
  • Description du dispositif
    120 V Neptune 3 Rover, Model Number: 0703-001-000
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA