Events

Rappel de GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;

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 3773 Corporate Pkwy Center Valley PA 18034-8217.

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
    76988
  • Classe de risque de l'événement
    Unclassified Correction
  • Date de mise en oeuvre de l'événement
    2017-03-28
  • Statut de l'événement
    Firm initiated action, Not yet classified 1
  • 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=154778
  • 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
    Motor, Surgical Instrument, Ac-Powered - Product Code GEY
  • Cause
    Diamond particulates may break off the burr and fall into the surgical site. if the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. these particulates could also lead to mechanically induced soft tissue damage.
  • Action
    On April 7, 2017 8 Hospitals, 3 distributors and 11 sales reps were sent an Urgent Medical Device Recall Notification letter. Letters were sent UPS overnight. Customers were asked to immediately discontinue use and return the product to Aesculap, Inc.

Device

GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2....
  • Modèle / numéro de série
    Model numbers COARSE:  GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ;  Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    CA, IL, NY, PA, TN, TX
  • Description du dispositif
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;
  • Manufacturer
    Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217

Manufacturer

Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217