Devices

Device Recall A.L.P.S

  • Model / Serial
    Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

Device Recall A.L.P.S., Distal Tibia Plating System
  • Model / Serial
    Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
  • Product Description
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
  • Manufacturer
    Biomet, Inc.
Device Recall A.L.P.S.
  • Model / Serial
    Part number:856135060 Lot: 061300
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Domestic: None. International: Netherlands and Japan
  • Product Description
    A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
  • Manufacturer
    Biomet, Inc.