Device Recall A.L.P.S

  • Modèle / numéro de série
    Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.
  • Description du dispositif
    A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. || Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    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

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
  • Description du dispositif
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
  • Manufacturer
  • Modèle / numéro de série
    Part number:856135060 Lot: 061300
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Domestic: None. International: Netherlands and Japan
  • Description du dispositif
    A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
  • Manufacturer