Device Recall Rees Insulated Forceps

  • Model / Serial
    Lot Number: 042308D08, 112108K08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 102607J07, 032607C07, and 041607D07.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including states of CA, FL, GA, ID, IL, IN, MA, MD, MS, NC, NH, NJ, NV, NY, OH, PA, TX, VA, WA, and WI, and countries of Norway, Canada, and Mexico.
  • Product Description
    BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PRODUCT***. The Rees Insulated Forceps are used during surgery to grasp, dissect and coagulate selected tissue. || Distributed by: || BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218, www.biometmicrofixation.com
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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