Device Recall Zimmer Oscillating Flat

  • Modèle / numéro de série
    Synvasive Part number: 11-4770; Part number: 19075127YT1;  Lot numbers: 45104 and 43054.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US Distribution to one location each in CT, MA and CA.
  • Description du dispositif
    Zimmer Oscillating Flat - TS ST Hub; || 75mm x 19mm x 1.00/1.27mm; || Synvasive Part No. 11-4770: || Part No. 19075127YT1; || Lot No. 45104 and 43054 || Description: STRYK_76542K_19X75X1.27T || General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • 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