Devices

Device Recall TMJ SYSTEM ARTHROSIMPLICITY Kit

  • 모델명 / 제조번호(시리얼번호)
    BP Syringe Codes 7298534, 7334153. Kit Lot #: 1107001,  1107002,  539500,  542870  542880  543090,  554890,  554900,  554920,  554930,  554940,  554950,  554970,  554980,  554990,  555000,  555010,  555020,  555030,  557720,  557730,  557750,  557790,  557800,  557810,  557820,  557830,  560540,  560550,  560560,  577500,  577510,  577520,  577530,  577560,  577590,  577600,  577610,  577620,  577630,  577640,  577650,  577660,  577680,  577690,  637110,  637120,  661250,  661270,  662960,  666880,  667830,  667850,  685230,  685240,  685250,  685260,  685770,  685780,  685790,  685800,  685810,  685820,  554870,  554880,  554910,  554960,  557780,  577540,  577550,  577570,  577580,  637130,  685760, and 698200.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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 ARTHROSIMPLICITY KIT REF 922070, 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

제조사

Biomet Microfixation, Inc.
  • 제조사 주소
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall TMJ SYSTEM ARTHROSIMPLICITY Kit
  • 모델명 / 제조번호(시리얼번호)
    BP Syringe Codes 7298534, 7334153. Kit Lot # 697060, 697090.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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 ARTHROSIMPLICITY KIT - EU REF 922075, 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.