Events

Rappel de Stryker

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 Stryker Howmedica Osteonics Corp..

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
    75015
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2789-2016
  • Date de mise en oeuvre de l'événement
    2016-08-01
  • Date de publication de l'événement
    2016-09-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149119
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    Upon failure of the press-fit, the clamping sub components and pins could disassociate from the scorpio patella assembly instrument.
  • Action
    Stryker sent an "Urgent Medical Device Recall Notification" Letter and Recall Business Reply Form dated August 1, 2016 to their affected customers via email and also via UPS on August 1, 2016. Customers are asked to quarantine the product subject to this recall. Branches/Agencies are asked to return all affected products available at their location to: Stryker C/O Stericycle, Attn: RA 2016-098 - Event 8296. Hospital/Branches: Customers are asked to complete and sign the Business Reply Form and fax a copy within 5 business days to: 877-272-6141 or email to Stericycle strykerortho8296@stericycle.com. Any questions, customers can call (201) 831-6693.

Device

Stryker
  • Modèle / numéro de série
    Catalog No. 3182-1000 Lot #'s: RD8E100, RD8A054TT, RD8A054T, RD8E099M, RD8E099A, RD8E099, RD8A054A, RD8E099D, RD8A053A, RD8A054, RD8A053T, RD7K062L, RD8A052A, RD8A052E, RD8A052, RD8A053, RD7E128D, RD5T290H, RD7E128T, RD5S262D, RD5T290W, RD7K062E, RD5S262X, RD7E128Y, RD7A076MA, RD6W102MA, RD7K062A, RD7K062, RD7E128H, RD7A076A, RD7E128A, RS7E128, RD6W103D, RD6V108J, RD6V108K, RD6V108H, RD7A076H, RD6V112M, RD7A074D, RD7A076J, RD6V112H, RD6W102m, RD5H286A, RD2V022, RD2K049, RD6W103, RD5H286J, RD2T037A, RD7A076M, RD6S136A, RD5H286, RD2V031C, RD5N361T, RD6V112A, RD4M068J, RD2V021C, RD7A076, RD6V112, RD4E226W, RD2V021, RD7A074H, RD6W102, RD4S220W, RD2V023X2, RD6W103A, RD6S136M, RD4M069D, RD2V023X3, RD6V108, RD5W148M, RD4S220, RD2V023, RD7A074, RD5M237K, RD4S220A, RD2V031A, RD7A074A, RD5T290X, RD4S220A1, RD2V023X1, RD6W103M, RD5T290A, RD4M069, RD2V031, RD5K116A, RD6S137A, RD4L128X1, RD2V031X2, RD5M236T, RD5W148A, RD4L128V, RD2V031X1, RD5K116T, RD6S137, RD4E226J, RD2N030K, RD3V002A, RD6S136, RD4M068< RD2T037, RD5M237, RD5W148X, RD4L128, RD2T037X, RD5K116N, RD5W148, RD4E226M, RD2N030E, RD5K116, RD5T290M, RD4E226L1, RD2N030S, RD5M236, RD5T290E, RD4C230L, RD2N030X, RD5H286L, RD5T290, RD4E226L, RD2N030XX, RD3T155L, RD5T290D, RD4E226, RD2N030, RD2V021E, RD5N361A, RD4C162L, RD2K068W, RD2V022W, RD5S305J, RD4C162, RD2N030X1, RD2V021S, RD5S305M, RD4C230, RD2M019E, RD2V022K, RD5N361M, RD4C230X, RD2M039, RD2V022E, RD5S305, RD3V002P, RD2M019H, RD2V021H, RD5S262A, RD3V002X1, RD2K049H, RD2V023E, RD5S262M1, RD3V002X2, RD2M003H, RD2T037W, RD5S262M, RD3V002D1, RD2M038H, RD2K068X1, RD5S262J, RD3V002, RD2K068B, RD2K068, RD5S262, RD3V002D, RD2M003, RD2K049R, RD5N361H, RD3V206D, RD2M038, RD2K049E, RD5M259M, RD3T160L1, RD2M019, RD2K017E, RD5N316, RD3V206X1, RD2K068S, RD2H056, RD5H286D, RD3T155L1, RD2K056S, RD2K056, RD5M259T, RD3T160L3, RD2K065S, RD2K065, RD5M236H, RD3T160, RD2K049S, RD2K017, RD5M259, RD3T160L2, RD2K068E, RD5M237L, RD3T160L, RD2H056E, RD5K116J, RD3V206, RD2K065E, RD4S220D, RD3T155 and RD2K056E
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide and Internationally
  • Description du dispositif
    Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) || The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA