Device Recall Disposable Coring Trephine

  • 모델명 / 제조번호(시리얼번호)
    Lot 804350, exp. 11/30/2014
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 제조사 모회사 (2017)
  • 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 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    648180 and 648200.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    821010 and 821020.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    92620
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    780470
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer