Devices

Device Recall Multipolar

  • Model / Serial
    Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
  • Product Description
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; || Item 00-5001-040-22 || Product Usage: || The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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 Multipolar Bipolar Cup Shell 48 mm O.D.,
  • Model / Serial
    Item Number: 00-5001-048-00 Lot Number: 62202263
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Product Description
    BIPOLAR METAL SHELL 48 MM OD || Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Multipolar Bipolar Cup
  • Model / Serial
    Part Number Range: 00-5001-038/072-00
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Product Description
    Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. || Indicated in fracture dislocation of the hip.
  • Manufacturer
    Zimmer, Inc.