Device Recall Zimmer

  • Model / Serial
    lot no: 61894346 61892658 61892659 61894347 61888124 61614768 62036752 62036753 62036754
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 8 consists of all products under product code HWC, and same usage: || Item no: || 47483501201 3.5MM CORT. SCREW 12MM LN || 47483501401 3.5MM CORT. SCREW 14MM LN || 47483501601 3.5MM CORT. SCREW 16MM LN || 47483501801 3.5MM CORT. SCREW 18MM LN || 47483503601 3.5MM CORT. SCREW 36MM LN || 47483507501 3.5MM CORT. SCREW 75MM LN || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Manufacturer Parent Company (2017)
  • 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

263 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot 2299218.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Florida, Pennsylvania, Texas and Virginia.
  • Product Description
    Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
  • Manufacturer
  • Model / Serial
    Lot 60954069.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Florida, China and India.
  • Product Description
    Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
  • Manufacturer
  • Model / Serial
    All units.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
  • Product Description
    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
  • Manufacturer
  • Model / Serial
    All lots.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
  • Product Description
    Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03. || The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
  • Manufacturer
  • Model / Serial
    Lots P050120 and P041466.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.
  • Product Description
    Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. || Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
  • Manufacturer
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