Devices

Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61907682 62038367 62106797 62161479 62240743 62268577 62344683 62030932 62106796 62148557 62206538 62240742 62303507 62352823
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 22 consists of all product under product code: JDI and same usage: || Item no: || 811400218 CPT 12/14 COCR REVISION S || 811400318 CPT 12/14 COCR REVISION S || 811400420 CPT 12/14 COCR REVISION S || 811400423 CPT 12/14 COCR REVISION S || 811400426 CPT 12/14 COCR REVISION S || 811400010 CPT 12/14 COCR SIZE 0 EXT || 811400000 CPT 12/14 COCR SIZE 0 STD || 811400110 CPT 12/14 COCR SIZE 1 EXT || 811400100 CPT 12/14 COCR SIZE 1 STD || 811400210 CPT 12/14 COCR SIZE 2 EXT || 811400200 CPT 12/14 COCR SIZE 2 STD || 811400230 CPT 12/14 COCR SIZE 2 XEX || 811400310 CPT 12/14 COCR SIZE 3 EXT || 811400300 CPT 12/14 COCR SIZE 3 STD || 811400330 CPT 12/14 COCR SIZE 3 XEX || 811400410 CPT 12/14 COCR SIZE 4 EXT || 811400400 CPT 12/14 COCR SIZE 4 STD || 811400430 CPT 12/14 COCR SIZE 4 XEX || 811400510 CPT 12/14 COCR SIZE 5 EXT || 811400500 CPT 12/14 COCR SIZE 5 STD || 811400530 CPT 12/14 COCR SIZE 5 XEX || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

제조사

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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 263 건

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Device Recall Zimmer Anatomical Shoulder Glenoid
  • 모델명 / 제조번호(시리얼번호)
    Lot 2385941.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Maryland.
  • 제품 설명
    Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer
  • 모델명 / 제조번호(시리얼번호)
    Lot No: 60646894.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer
  • 모델명 / 제조번호(시리얼번호)
    Lot No: 60651168 and 60726506.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • 제품 설명
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain
  • 모델명 / 제조번호(시리얼번호)
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • 제품 설명
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
    Zimmer Inc.
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