Device Recall adjustable drill stop

  • Modèle / numéro de série
    Lot Numbers: EM09F012, EM09F013, EM09F014, EM09F015, EM09F016, EM09F017, EM10A010, EM10A0101, EM11G042, IM83002, IT03G009, IT03H011, IT03J035, IT03M011, IT04A007, IT04C015, IT04D025, IT04F005, IT04G001, IT06A014, IT06A0141, IT06L042, IT07C028, IT09891, IT09892, IT09953, IT10050, IT10051, IT10308, IT10808, IT10906, IT10907, IT11222, IT11698, IT11874, SK10341, SK10777
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
  • Description du dispositif
    PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || Product Usage: || Manual orthopedic adjustable drill stop
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Numbers: 730, 15505, 27527, 28134, 29419, 29430, 31158, 33861, 34004, 35521, 38507, 38843, 41963, 43416, 43725, 49011, 49017, 50586, 50587, 53065, 53386, 53894, 55388, 56074, 62942, 64271, 65090, 65565, 79884, 83604, FA07M031, FA08A004, FA08E004, FA08H001, FA08H027, FA08J008, FA09J007, FA09J007L, FA10F036, FA10J007, FA10L012, FA11A024, FA11F004, FA11G011, FA11H055, IT03G024, IT03H012, IT03J010, IT03J039, IT03K048, IT04D024, IT05M002, IT06L043, IT07D014, IT07G041, IT07J024, IT07J088, IT10113, IT10336, IT10411, IT10412, IT10413, IT10966, IT10967, IT10968
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
  • Description du dispositif
    ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || Product Usage: || Manual orthopedic adjustable drill stop
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 61624, 61670, SK10341, SK10777, SK07G002
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
  • Description du dispositif
    VERTEX MAX (R) Cannulated, VERTEX MAX (R), and VERTEX (R) Reconstruction System Adjustable Drill Stop, REF 6860460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || Product Usage: || Manual orthopedic adjustable drill stop
  • Manufacturer