Devices

Device Recall TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT

  • Modèle / numéro de série
    BP Syringe Codes 7298534, 7334153. Kit Lot # 617170, 617380,  617390,  617400,  617410,  617420,  617430,  617440,  617450,  617460,  617470,  617480,  617490,  617500,  617510,  617530,  620930,  620940,  620950,  620960,  623050,  623060,  623070,  623080,  623090,  623110,  623190,  623200,  623220,  632200,  637940,  658150,  674330,  674340,  674350,  674380,  674400,  674410,  674420,  674430,  674450,  674460, 674470,  674480, and 674490.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
  • Description du dispositif
    BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT, REF 922090, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
  • Manufacturer
    Biomet Microfixation, Inc.
  • 1 Event

Fabricant

Biomet Microfixation, Inc.
  • Adresse du fabricant
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT
  • Modèle / numéro de série
    BP Syringe Codes 7298534, 7334153. Biomet Kit Code 24-3055.  Kit Lot # 724760 (2),  724770,  729260,  729270,  729280,  729290,  729300,  731220, and 731230.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
  • Description du dispositif
    BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT - BJ REF 24-3055, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
  • Manufacturer
    Biomet Microfixation, Inc.
Device Recall TMJ SYSTEM InnerVuie SCOPE PROCEDURE KIT
  • Modèle / numéro de série
    BP Syringe Codes 7298534, 7334153. Kit Lot #755600,  724620,  724630,  724640,  724650,  724660,  724670,  724680,  724690,  724700,  724710,  724800,  724810,  724820,  724830,  724840,  729200,  729210,  729220,  729230,  729240,  729250,  729320,  729330,  729340,  729380,  729390,  729400,  729410,  729420,  729430,  729440,  729450,  729460,  729470,  729480,  729500,  729540,  729570,  729580,  729590,  729600,  729610,  731120,  731130,  731140,  731150,  731160,  731350,  731360,  755580,  755590,  755610,  755620,  729360, and 729370.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
  • Description du dispositif
    BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT, REF 24-3050, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
  • Manufacturer
    Biomet Microfixation, Inc.