Events

Device Recall Trauma Tubes and Plates 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-2550-2014
  • 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=129074
  • 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
    Plate, fixation, bone - Product Code HRS
  • 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 Trauma Tubes and Plates
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514      EXPIRATION DATE PRIOR TO 2024-07
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Trauma Tubes and Plates: || TUBE & SCP PLT 90DX150LG || TUBE & SCP PLT 90DX205LG || TUBE & SCP PLT 90DX255LG || TUBE & SCP PLT 95DX150LG || TUBE & SCP PLT 95DX205LG || TUBE & SCP PLT 95DX255LG || TUBE&SCP; PLT 130DX8H || TUBE&SCP; PLT 130DX10H || TUBE&SCP; PLT 130DX12H || TUBE&SCP; PLT 130DX14H || TUBE&SCP; PLT 135DX8H || TUBE&SCP; PLT 135DX10H || TUBE&SCP; PLT 135DX12H || TUBE&SCP; PLT 135DX14H || TUBE&SCP; PLT 140DX8H || TUBE&SCP; PLT 140DX10H || TUBE&SCP; PLT 140DX12H || TUBE&SCP; PLT 140DX14H || TUBE&SCP; PLT 145DX8H || TUBE&SCP; PLT 145DX10H || TUBE&SCP; PLT 145DX12H || TUBE&SCP; PLT 145DX14H || TUBE&SCP; PLT 150DX6H || TUBE&SCP; PLT 150DX8H || TUBE&SCP; PLT 150DX10H || TUBE&SCP; PLT 150DX12H || TUBE&SCP; PLT 150DX14H || VERSA-FX II SC TUBE PLT 90DX6H || VERSA-FX II SC TUBE PLT 90DX8H || VERSA-FXII SC TUBE PLT 90DX10H || VERSA-FXII SC TUBE PLT 90DX12H || VERSA-FXII SC TUBE PLT 90DX14H || VERSA-FXII SC TUBE PLT 95DX6H || VERSA-FXII SC TUBE PLT 95DX8H || VERSA-FXII SC TUBE PLT 95DX10H || VERSA-FXII SC TUBE PLT 95DX12H || VERSA-FXII SC TUBE PLT 95DX14H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE || VERSA-FX II STD TUBE 130DX8H || VERSA-FX II STD TUBE 130DX10H || VERSA-FX II STD TUBE 130DX12H || VERSA-FX II STD TUBE 130DX14H || VERSA-FX II STD TUBE 135DX8H || VERSA-FX II STD TUBE 135DX10H || VERSA-FX II STD TUBE 135DX12H || VERSA-FX II STD TUBE 135DX14H || VERSA-FX II STD TUBE 140DX8H || VERSA-FX II STD TUBE 140DX10H || VERSA-FX II STD TUBE 140DX12H || VERSA-FX II STD TUBE 140DX14H || VERSA-FX II STD TUBE 145DX8H || VERSA-FX II STD TUBE 145DX10H || VERSA-FX II STD TUBE 145DX12H || VERSA-FX II STD TUBE 145DX14H || VERSA-FX II STD TUBE 150DX8H || VERSA-FX II STD TUBE 150DX10H || VERSA-FX II STD TUBE 150DX12H || VERSA-FX II STD TUBE 150DX14H || VERSA-FX II KEYLESS TB 130DX8H || VERSA-FX II KEYLESS TB 135DX8H || VERSA-FX II KEYLESS TB 140DX8H || VERSA-FX II KEYLESS TB 145DX8H || VERSA-FX II KEYLESS TB 150DX8H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE
  • 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