Events

Rappel de Device Recall GENESIS II/LEGION Resurfacing Patella with JOURNEY Peg

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 Smith & Nephew, Inc..

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
    72866
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0573-2016
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • Date de publication de l'événement
    2016-01-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142377
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    One lot of 35 mm patella implants is labeled as 32 mm. these implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
  • Action
    The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: FieldActions@smith-nephew.com, even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: jason.sells@smith-nephew.com.

Device

Device Recall GENESIS II/LEGION Resurfacing Patella with JOURNEY Peg
  • Modèle / numéro de série
    Batch # 15GM07831
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to states of:FL, MO, IN and TX.
  • Description du dispositif
    Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 || knee implant.
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA