Events

Device Recall Knee Stem Extensions & Impactor Sleeve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    68818
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2552-2014
  • 사례 시작날짜
    2014-07-22
  • 사례 출판 날짜
    2014-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129077
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • 조치
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Knee Stem Extensions & Impactor Sleeve
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers:00598801020, 00598801022, 00598801024, 00598801520, 00598801522, 00598801524, 00598801620, 00598801622, 00598801624, 00598801913, 31810604200, 32598801212, 32598801213, 32598801214, 32598801215, 32598801216, 32598801217, 32598801218, 32598801220, 32598801222, 621519095, 621519115, 621519135, 621519155, 621519175, 621520105, 621520125, 621520145, 621520165, 621520185, 621525105, 621525125, 621525145, 621525165, 681515125, 681515145, 681515165, 681515185, 681515205, 681517125, 681517145, 681517165, 681517185, 681517205, 681517225, 681519105, 681519115, 681519125, 681519135, 681519145, 681519165, 681519185   EXPIRATION DATE PRIOR TO 2024-07
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Knee Stem Extensions & Impactor Sleeve: || STEM IMPLANT 20MMDX145MM || STEM IMPLANT 22MMDX145MM || STEM IMPLANT 24MMDX145MM || SHARP FLUTED ST 20MMDX75MM || SHARP FLUTED ST 22MMDX75MM || SHARP FLTD ST 24MMDX75MM || SHARP FLUTED ST 20MMDX130MM || SHARP FLUTED ST 22MMDX130MM || SHARP FLUTED ST 24MMDX130MM || CEMENTED STEM EXT 13MM X 145MM || IMPACTOR SLEEVE* || NGK STEM EXT 12X245MM (200MM) || NGK STEM EXT 13X245MM (200MM) || NGK STEM EXT 14X245MM (200MM) || NGK STEM EXT 15X245MM (200MM) || NGK STEM EXT 16X245MM (200MM) || NGK STEM EXT 17X245MM (200MM) || NGK STEM EXT 18X245MM (200MM) || NGK STEM EXT 20X245MM (200MM) || NGK STEM EXT 22X245MM (200MM) || SMOOTH REV STM 9.5MM X 19 || SMOOTH REV STM 11.5MM X 1 || SMOOTH REV STM 13.5MM X 1 || SMOOTH REV STM 15.5MM X 1 || SMOOTH REV STM 17.5MM X 1 || REV FEM STM 10.5MM X 200M || REV FEM STM 12.5MM X 200M || REV FEM STM 14.5MM X 200M || REV FEM STM 16.5MM X 200M || 18.5X200MM REV STEM || REV FEM STM 10.5MM X 250M || REV FEM STM 12.5MM X 250M || REV FEM STM 14.5MM X 250M || REV FEM STM 16.5MM X 250M || 12.5X155MM FLUTED OFFST R || 14.5X155MM FLUTED OFFST R || 16.5X155MM FLUTED OFFST R || 18.5X155MM FLUTED OFFST R || 20.5X155MM FLUTED OFFST R || 12.5X175MM FLUTED REV STM || FLUTE REV STEM - 14.5MM X || FLUTE REV STEM - 16.5MM X || FLUTE REV STEM - 18.5MM X || FLUTE REV STEM - 20.5MM X || FLUTE REV STEM - 22.5MM X || FLUTED REV STM 10.5MM X 1 || FLUTED REV STM 11.5MM X 1 || FLUTED REV STM 12.5MM X 1 || FLUTED REV STM 13.5MM X 1 || FLUTED REV STM 14.5MM X 1 || FLUTED REV STM 16.5MM X 1 || FLUTED REV STM 18.5MM X 1
  • Manufacturer
    Zimmer, Inc.

Manufacturer

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