Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 62233575 62255244
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 25 consists of all product under product code: LPH and same usage: || Item no: || 234703104 DISTAL MEDIAL FEMORAL CON || 234703206 DISTAL MEDIAL FEMORAL CON || 234703208 DISTAL MEDIAL FEMORAL CON || 234800504 DISTAL POSTERIOR/LATERAL || 234800506 DISTAL POSTERIOR/LATERAL || 234800508 DISTAL POSTERIOR/LATERAL || 234800510 DISTAL POSTERIOR/LATERAL || 234800604 DISTAL POSTERIOR/LATERAL || 234800606 DISTAL POSTERIOR/LATERAL || 234800608 DISTAL POSTERIOR/LATERAL || 234800610 DISTAL POSTERIOR/LATERAL || 234800614 DISTAL POSTERIOR/LATERAL || For use in total 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

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 63716611; UDI: (01)00889024131736(17)270731(10)63716611
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • 제품 설명
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.
  • 제품 설명
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00-5926-011-01 Knee PFJ FEM, CEMENTED, SZ 1, LEFT  00-5926-012-01 Knee PFJ FEM, CEMENTED, SZ 2, LEFT  00-5926-013-01 Knee PFJ FEM, CEMENTED, SZ 3, LEFT  00-5926-013-02 Knee PFJ FEM, CEMENTED, SZ 3, RIGHT 00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT 00-5926-015-02 Knee PFJ FEM, CEMENTED, SZ 5, RIGHT
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00-5926-014-02 Knee PFJ FEM, CEMENTED, SZ 4, RIGHT
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    ZIMMER PATELLA FEMORAL JOINT¿ || Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    00-5842-012-02 61777606 00-5842-012-02 61774093 00-5842-013-01 61774095 00-5842-013-02 61777611 00-5842-014-01 11002921 00-5842-014-01 61777613 00-5842-014-02 61777615 00-5842-014-02 61777616 00-5842-015-01 61777617 00-5842-016-02 61756843
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    ZUK PRC FEM SZB RMED/LLAT¿ || ZUK PRC FEM SZC LMED/RLAT¿ || ZUK PRC FEM SZC RMED/LLAT¿ || NGU PRC FEM SZD LMED/RLAT¿ || ZUK PRC FEM SZD RMED/LLAT¿ || ZUK PRC FEM SZE LMED/RLAT || ZUK PRC FEM SZF RMED/LLAT || " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
  • Manufacturer
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