Device Recall Ziptight Ankle Syndesmosis Fixation

  • Model / Serial
    Lot #: 058860, 058880, 058890, 058910, 116030, 169780, 169790, 213450, 213480, 374420, 392530, 476670, 503830, 614910, 670640, 728190, 984070, 984080;  UDI #:  (01)00880304476103(17)220523(10)058860,  (01)00880304476103(17)220608(10)058880,  (01)00880304476103(17)220608(10)058890,  (01)00880304476103(17)220608(10)058910,  (01)00880304476103(17)220519(10)116030,  (01)00880304476103(17)220609(10)169780,  (01)00880304476103(17)220608(10)169790,  (01)00880304476103(17)220609(10)213450,  (01)00880304476103(17)220607(10)213480,  (01)00880304476103(17)220319(10)374420,  (01)00880304476103(17)220610(10)392530,  (01)00880304476103(17)220607(10)476670,  (01)00880304476103(17)220608(10)503830,  (01)00880304476103(17)220421(10)614910,  (01)00880304476103(17)220621(10)670640,  (01)00880304476103(17)220606(10)728190,  (01)00880304476103(17)220512(10)984070,  (01)00880304476103(17)220607(10)984080
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Argentina, Australia, Canada, Costa Rica, Japan, and Netherlands.
  • Product Description
    Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Item No. 905759, Lot No. (UDI No.): 58860 ((01)00880304476103(17)220523(10)058860), 58880 ((01)00880304476103(17)220608(10)058880), 58890 ((01)00880304476103(17)220608(10)058890), 58910 ((01)00880304476103(17)220608(10)058910), 116030 ((01)00880304476103(17)220519(10)116030), 169780 ((01)00880304476103(17)220609(10)169780), 169790 ((01)00880304476103(17)220608(10)169790), 213450 ((01)00880304476103(17)220609(10)213450), 213480 ((01)00880304476103(17)220607(10)213480), 374420 ((01)00880304476103(17)220319(10)374420), 392530 ((01)00880304476103(17)220610(10)392530), 476670 ((01)00880304476103(17)220607(10)476670), 503830 ((01)00880304476103(17)220608(10)503830), 614910 ((01)00880304476103(17)220421(10)614910), 670640((01)00880304476103(17)220621(10)670640), 728190 ((01)00880304476103(17)220606(10)728190), 984070 ((01)00880304476103(17)220512(10)984070), 984080 ((01)00880304476103(17)220607(10)984080)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
  • Product Description
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
  • Manufacturer