Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 62012579 62086025 62086025N 62055993 62264285 62362923 62264285N 62151833 62284483 62362921 62284483N 62224932 62284484 62340084 61886896 62043474 62141793 62284485 62362930 62284485N 62240754 62293494
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 57 consists of all product code: JDI and same usage: || Item no: || 763401000 PRESSFIT FEM ST FX 10 X 115 || 763401100 PRESSFIT FEM ST FX 11 X 1 || 763401200 PRESSFIT FEM ST FX 12 X 1 || 763401300 PRESSFIT FEM ST FX 13 X 1 || 763401400 PRESSFIT FEM ST FX 14 X 1 || 763401500 PRESSFIT FEM ST FX 15 X 1 || For use in total or hemi hip arthroplasty
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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 263 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    lot # 60869302 and lot # 60963801
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • 제품 설명
    Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot #'s: 60544910, 60750863 and 60902482
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • 제품 설명
    Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot #'s: 60806992 and 60921166
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • 제품 설명
    Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot #'s: 60636760, 60723667 and 60896770.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • 제품 설명
    Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot #'s: 60530181, 60587803, 60739782, 60826082, and 60963803.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • 제품 설명
    Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
하나 더 258 건 더