Device Recall various polyethylene implants Custom parts

  • Model / Serial
    Items and lots: Item 110010452 732130 920720 Item 110010454 136510 Item 110010455 752320 896040 Item 110010456 383320 879930 Item 110010459 854290 879950 905350 Item 110010462 752460 778490 Item 110010468 827730 Item 110010476 827530 827540 Item 110010716 753050 ItemCP753453 655990 ItemCP753455 656110 ItemCP753461 382210 Item CP753470 436530 Item CP753476 502920 Item CP753478 524950 Item CP753480 436460 Item CP753486 655300 Item CP753488 655470 Item CP753494 467390 Item CP753496 467420 Item CP753502 448730 Item CP753504 453990 Item CP753506 454640 Item CP753508 502970 Item CP753510 831310 Item CP753512 654720 Item CP753514 594570 Item CP753517 594630 Item CP753519 534820 Item CP753521 535090 Item CP753523 654190 Item CP753525 674160 Item CP753531 691490 Item CP753533 691560 Item CP753535 691640 Item CP753537 691680 Item CP753547 691720 Item CP753549 696620
  • Distribution
    Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK
  • Product Description
    various polyethylene implants || Custom parts || Product Usage: || Custom
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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