Device Recall Bigliani/Flatow

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog number 47-4307-031-00; lot 62071190
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide: TX, FL, MS, MI, OH, KS, TN, KY, OK, UT, CO, CA, IL, NC, NJ, ND, and WI.
  • Description du dispositif
    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
  • Manufacturer
  • Modèle / numéro de série
    Item 00-4301-012-17; lot 62283991
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including IL and MO.
  • Description du dispositif
    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm || This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
  • Manufacturer
  • Modèle / numéro de série
    Item Number: 00-4305-019-40 with Lot Numbers 61588143 and 61612276. 2010 Market Withdrawal: Item #:430501940 Lot #'s: 60768814, 60806551, 60893241, 60946820, 60999665, 61031668, 61110808, 61170678, 61205673, 61244194, 61392456, 61430127
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.
  • Description du dispositif
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. || Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
  • Manufacturer
  • Modèle / numéro de série
    Item Number 00-4305-019-30 with Lot Numbers 61557761, 61591732, 61612275, 61614764, and 77000186. 2010 Market Withdrawal part numbers: Item #:430501930, Lot#s: 60795817, 60834923, 60916795, 60997103, 61017041, 61038697, 61075510, 61128521, 61186400, 61199809, 61253702, 61392455, 61430126
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of NY, MI, MN, OH, IN, IL, VA, MD, PA, WA, KY, CT, RI, NH, TX, MT, and CA and the countries of Chile, China, South Korea, and Australia.
  • Description du dispositif
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. || Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
  • Manufacturer