Device Recall Persona Partial Knee

  • Modèle / numéro de série
    (1) 8mm block, Model Number: 42-5399-035-08, Lots: 63767442 and 63807190; (2) 9mm block, Model Number:42-5399-035-09, Lot: 63769804; (3) 10mm block, Model Number: 42-5399-035-10, Lot: 63769805; (4) 12mm block, Model Number: 42-5399-035-12, Lot: 63769806; (5) 14mm block, Model Number: 42-5399-035-14, Lots: 63767443 and 63813674
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI., and Internationally to Japan and Netherlands.
  • Description du dispositif
    Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 || A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
  • 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. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
  • Description du dispositif
    Persona Partial Knee System, Size 8, Finishing Guide
  • Manufacturer