Device Recall Osteotome Chisel

  • Model / Serial
    Models: 26.08.506 OSTEO 8MM AND W/HDL 20CM/8IN 26.08.507 OSTEO 10MM AND W/HDL 20CM/8IN 26.08.508 OSTEO 12MM AND W/HDL 20CM/8IN 26.08.509 OSTEO 13MM CRVD R 10 23CM/9IN 26.08.619 OSTEO 19MM CRVD R 10 23CM/9IN (No US distribution) 26.08.712 OSTEO 12MM CRVD R 6 23CM/9IN (No US distribution) 26.08.715 OSTEO 15MM CRVD R 6 23CM/9IN (No US distribution) 26.08.718 CHARC OSTE 18MM CRD R6 23CM/9 26.08.812 OSTEO 12MM CRVD R 8 23CM/9IN (No US distribution) 26.08.815 OSTEO 15MM CRVD R 8 23CM/9IN (No US distribution) 26.08.818 CHARC OSTE 18MM CRD R8 23CM/9 (No US distribution) 26.08.900 ARTHROPIC ARTH 18CM 45TUFF HDL 26.08.910 RUTREK CHIS 20CM/8 DBL CUT BLD
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CO, IN, TX, IL
  • Product Description
    Normed Charcot Osteotome Chisel (Various sizes)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer GmbH, Sulzerallee 8, Winterthur Switzerland
  • 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