Devices

Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61932449 62126613 62204611 62213348 62406239 62203954 62204587 62332733 62236654 62406245
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 34 consists of all product under product code: JWH and same usage: || Item no: || 522001700 I/B II KNEE DOMED PATELLA || 522001800 I/B II KNEE DOMED PATELLA || 522001900 I/B II KNEE DOMED PATELLA || for use in total knee 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

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Device Recall Zimmer PSI Knee Persona" Jigs (Patient Specific Instrumentation)
  • 모델명 / 제조번호(시리얼번호)
    BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01;  Expiration dates 5/8/14-12/31/15
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution in states of: AZ, CO, IL, OR, and WA.
  • 제품 설명
    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer || The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
  • Manufacturer
    Zimmer CAS
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.
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