Device Recall Zimmer Air Dermatome II Width Plate, 1.5 inch

  • Model / Serial
    Lot # 61999884, Serial # N/A Lot # 62267513, Serial # N/A Lot # 62635782, Serial # N/A
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
  • Product Description
    Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. || Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. || The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Surgical Inc, 200 W Ohio Ave, Dover OH 44622-9642
  • 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