Device Recall Vanguard Knee

  • Modèle / numéro de série
    Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265; Lot No's: ZB160701, ZB160702, ZB160703, ZB160701, ZB160702, ZB160701, ZB160702, ZB160703, ZB160801, ZB160802, ZB160803, ZB160801, ZB160802
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Domestic: 0 Foreign: Singapore & Malaysia
  • Description du dispositif
    Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150;  UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480;  UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730;  UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370;  UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750;  UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970;  UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680;  UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370;  UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470;  UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060;  UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330;  UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220;  UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080;  UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.
  • Description du dispositif
    Vanguard Knee System PS Tibial Bearing, Part Number 183621 || Intended for use in knee joint replacement procedures.
  • Manufacturer