Device Recall Ziptight Ankle Syndesmosis Fixation

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Argentina, Australia, Canada, Costa Rica, Japan, and Netherlands.
  • Description du dispositif
    Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    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)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
  • Manufacturer