Device Recall Zimmer Natural Nail System Tear Drop Guide Wire

  • 모델명 / 제조번호(시리얼번호)
    All Lot Numbers Expiry Date Before April 2022
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 || Product Usage: || The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

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  • 모델명 / 제조번호(시리얼번호)
    All Lot Numbers Expiry Date Before March 2022
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 || Product Usage: || The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63631729 63638177 63645647 63645648 63662542 63681727 63690177 63690178 63733040 63733041 63733042 63748389 63753764 63758424 63771141 63780123 63787478 63826236 77006549 77006550 77006551 77006553 77006558 63836288
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63733044 63748390 63748391 77006546 77006547 77006548
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63609177 63631715 63638172 63638173 63638175 63638176 63645643 63645644 63655990 63655991 63655992 63655993 63655994 63662538 63662539 63662540 63662541 63668694 63668695 63668696 63668697 63675668 63675669 63675670 63675704 63675705 63681724 63681726 63681728 63690176 63690179 63690180 63705228 63705229 63709163 63709164 63709165 63709166 63715680 63715681 63715682 63715683 63721368 63721369 63721370 63721371 63731169 63748392 63753760 63753761 63753762 63753763 63758420 63758421 63758422 63758423 63771066 63771067 63780119 63780120 63780121 63780122 63781875 63781876 63781877 63781878 63787475 63787476 63787477 63796531 63796532 63796533 63796534 63796535 63803579 63803581 63803583 63803591 63803592 63812281 63812283 63812284 63812285 63817702 63817704 63817705 63844026 63812282 63817701 63826234 63826235 63836285 63844028
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  63631719 63668698 63705230 63705231 63731168 63771071 63787479
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
  • 제품 설명
    Zimmer Natural Nail System Tear Drop Guide Wire || 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
  • Manufacturer