Events

Rappel de Device Recall Modular SMF(TM)

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
    75873
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0945-2017
  • Date de mise en oeuvre de l'événement
    2016-11-15
  • 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=151584
  • 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, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Cause
    All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
  • Action
    Smith & Nephew sent an Urgent Product Recall Notification letter dated November 15, 2016, to all affected customers. Customers were instructed to inspect their inventory and locate any unused devices and quarantine immediately. Complete the Inventory Return Certification Form and obtain a return authorization (RA) number if there was product to return. For questions regarding this recall call 978-749-1440.

Device

Device Recall Modular SMF(TM)
  • Modèle / numéro de série
    71352401 SMF STEM RSA SIZE 1 71352402 SMF STEM RSA SIZE 2 71352403 SMF STEM RSA SIZE 3 71352404 SMF STEM RSA SIZE 4 71352405 SMF STEM RSA SIZE 5 71352406 SMF STEM RSA SIZE 6 71352407 SMF STEM RSA SIZE 7 71352408 SMF STEM RSA SIZE 8 71352409 SMF STEM RSA SIZE 9 71352501 SMF STEM WITH STIKTITE SZ 1 71352502 SMF STEM WITH STIKTITE SZ 2 71352503 SMF STEM WITH STIKTITE SZ 3 71352504 SMF STEM WITH STIKTITE SZ 4 71352505 SMF STEM WITH STIKTITE SZ 5 71352506 SMF STEM WITH STIKTITE SZ 6 71352507 SMF STEM WITH STIKTITE SZ 7 71352508 SMF STEM WITH STIKTITE SZ 8 71352509 SMF STEM WITH STIKTITE SZ 9
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Canada, Switzerland, China, Cyprus, Czech Republic, Dubai, Germany, Denmark, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Mexico, Netherlands, Poland, Puerto Rico, Portugal, Russia, Turkey, and South Africa.
  • Description du dispositif
    Modular SMF(TM) || The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are intended for single use only and are to be implanted without bone cement.
  • 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