Events

Rappel de ELAN 4

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 Aesculap Implant Systems 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
    79068
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0621-2018
  • Date de mise en oeuvre de l'événement
    2017-09-05
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161272
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Cause
    Elan 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
  • Action
    Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.

Device

ELAN 4
  • Modèle / numéro de série
    All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to 4 hospitals in the following states: NM, OH, TX, WV
  • Description du dispositif
    ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 || ELAN 4 1-RING NEURO CUTTER SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER D2.0 || ELAN 4 1-RING NEURO CUTTER D2.5 || ELAN 4 1-RING NEURO CUTTER D3.0 || ELAN 4 1-RING NEURO CUTTER TC D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 || ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG || ELAN 4 2-RING NEURO CUTTER SOFT D2,0 || ELAN 4 2-RING NEURO CUTTER SOFT D2,5 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER TC D3,0 || ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 || ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 || ELAN 4 2-RING DIAMOND DISC || ELAN 4 2-RING SIDE CUTTER TC D3,0 || SAW BLADE S sagittal 11/13/0,3 || SAW BLADE S sagittal 15/5/0,3 || SAW BLADE S sagittal 20/5/0,3 || SAW BLADE S sagittal 20/10/0,3 || SAW BLADE S sagittal 20/15/0,3 || SAW BLADE S sagittal 25/5/0,3 || SAW BLADE S sagittal 25/12/0,3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || ELAN 4 1-RING NEURO CUTTER D1.5+ || ELAN 4 1-RING NEURO CUTTER D2.0+ || ELAN 4 1-RING NEURO CUTTER D2.5+ || ELAN 4 1-RING NEURO CUTTER D3.0+ || ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 || ELAN 4 1-RING NEURO PRECISE D1.5 || ELAN 4 1-RING NEURO PRECISE D2.0 || ELAN 4 1-RING NEURO PRECISE D2.5 || ELAN 4 1-RING NEURO PRECISE D3.0 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Adresse du fabricant
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA