Events

Rappel de Device Recall SROM Noiles Rotating Hinge Femur with Pin

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 DePuy Orthopaedics, 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
    67627
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1204-2014
  • Date de mise en oeuvre de l'événement
    2014-02-24
  • Date de publication de l'événement
    2014-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125863
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Cause
    Depuy orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for s-rom¿ noiles rotating hinge femur with pin devices. the outer carton and shrink wrap are intact. a package redesign is underway to resolve this issue. s-rom noiles rotating hinge femur with pin devices will remain in us distributors inventory during the p.
  • Action
    DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to DePuy. Product related questions should be addressed to DePuy Orthopaedics, .Sales Consultant. Clinical questions should be addressed to DePuy Scientific Information Office 1-888-554-2482; recall questions to 574-371-4917.

Device

Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • Modèle / numéro de série
    102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • Description du dispositif
    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA