Devices

Device Recall Micromax Anchors

  • 모델명 / 제조번호(시리얼번호)
    006550 , 006560 , 040390 , 040400 , 040410 , 050660 , 088350 , 193460 , 230570 , 291900 , 291910 , 291920 , 295550 , 680400 , 756050 , 781010 , 926440
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
  • 제품 설명
    REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN || Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

제조사

Biomet, Inc.
  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

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Device Recall Micromax Anchors
  • 모델명 / 제조번호(시리얼번호)
    056730, 056760, 056770, 056780 , 056790, 056800, 056810, 222180, 222190, 222200, 222210, 222220, 222230, 222240, 222250, 222260, 222270, 222280, 222290, 222300.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
  • 제품 설명
    REF 905463, 2.9 mm Micromax Anchor Long Shaft, Size 2 Blue/White Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN || Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
  • Manufacturer
    Biomet, Inc.
Device Recall Micromax Anchors
  • 모델명 / 제조번호(시리얼번호)
    006500, 072300, 130540, 352960, 352970, 379540, 379550, 435430, 450680, 463730, 463740, 463750, 463760, 464260, 464270, 464280, 520700, 520710, 573090, 756020, 902250
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
  • 제품 설명
    REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN || Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
  • Manufacturer
    Biomet, Inc.
Device Recall Micromax Anchors,
  • 모델명 / 제조번호(시리얼번호)
    40370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 83271040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 37793040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
  • 제품 설명
    REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN || Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
  • Manufacturer
    Biomet, Inc.