Device Recall Zimmer

  • Model / Serial
    lot no.: 62133636 61882374 61964347 61987304 62133643 62171285 62298481 61969229 62080367 62292385 61657722 61930479 61930480 61930481 62109268 61136016 61930482 62098917 62098918 61764507 61764508 61764509 61895897 61895905 61895907 61895908
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 55 consists of all product under product code: HSB and same usage: || Item no: || 225900132 ONE-PIECE LAG SCREW 11MM || 225900135 ONE-PIECE LAG SCREW 11MM || 225900137 ONE-PIECE LAG SCREW 11MM || 225900140 ONE-PIECE LAG SCREW 11MM || 225900142 ONE-PIECE LAG SCREW 11MM || 225900145 ONE-PIECE LAG SCREW 11MM || 225900152 ONE-PIECE LAG SCREW 11MM || Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • 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 Number: 61007046.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
  • Product Description
    Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02. || Orthopedic implant used in total hip arthroplasty.
  • Manufacturer
  • Model / Serial
    Lot Number: 60917793.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.
  • Product Description
    Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. || Orthopedic implant used in total hip arthroplasty.
  • Manufacturer
  • Model / Serial
    Lots 60633223 and 60740476.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
  • Product Description
    Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00.
  • Manufacturer
  • Model / Serial
    Lots 60639048 and 60657449.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA, China, Germany, Japan, Korea and Thailand.
  • Product Description
    Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States).
  • Manufacturer
  • Model / Serial
    Lot Number: 61229259.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada and Japan.
  • Product Description
    Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. || Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.
  • Manufacturer
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