Events

Device Recall Zimmer Air Dermatome II handpiece 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Surgical 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
    74636
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2334-2016
  • 사례 시작날짜
    2016-07-04
  • 사례 출판 날짜
    2016-08-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148075
  • 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
    Dermatome - Product Code GFD
  • 원인
    The surface coating applied to the device is blistering, peeling and discoloring after usage over time.
  • 조치
    The firm, Zimmer Biomet Surgical, sent an "URGENT MEDICAL DEVICE RECALL CORRECTION NOTICE" dated 7/6/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Carefully review this letter and ensure all users of the Zimmer Air Dermatome II at your facility have been informed of this notice. 2. Inspect the Zimmer Air Dermatome II devices within your facility and indicate on the attached Certificate of Acknowledgment the condition of the device. Complete and sign the attached Certificate of Acknowledgment and return it to corporatequality.postmarket@zimmerbiomet.com. 3. Before each use, continue to examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are not present, you may continue to use. Immediately after each use, re-examine the surface coating for blistering/peeling. If the blistering/peeling characteristics are present, discontinue use. In the event that alternate devices or therapies are not available, surgeons may, at their discretion, determine the use of the device as a medical necessity and continue to use. After use, follow your facilitys wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for gray coating flakes and continue to irrigate as necessary. Report this as an adverse event to Zimmer Biomet Surgical at SurgicalRegulatoryReporting@zimmerbiomet.com. If after reviewing this notification you have further questions or concerns please call 1-330-364-0989 between 8:00 am and 5:00 pm EST, Monday through Friday.

Device

Device Recall Zimmer Air Dermatome II handpiece
  • 모델명 / 제조번호(시리얼번호)
    Lot # 61977101, Serial # 500001  500019 Lot # 61980678, Serial # 500021  500040 Lot # 61989398, Serial # 500081  500090 Lot # 62008619, Serial # 500091  500110 Lot # 62083340, Serial # 500151  500170 Lot # 62096333, Serial # 500171  500190 Lot # 62122378, Serial # 500191  500210 Lot # 62191658, Serial # 500211  500230 Lot # 62191665, Serial # 500231  500250 Lot # 62220857, Serial # 500251  500270 Lot # 62220882, Serial # 500291  500310 Lot # 62244236, Serial # 500331  500350 Lot # 62266024, Serial # 500351  500371 Lot # 62267510, Serial # 500372  500391 Lot # 62267596, Serial # 500452  500471 Lot # 62289834, Serial # 500412  500431 Lot # 62309628, Serial # 500472  500491 Lot # 62309698, Serial # 500512  500531 Lot # 62369392, Serial # 500532  500551 Lot # 62374685, Serial # 500552  500571 Lot # 62374721, Serial # 500592  500611 Lot # 62393971, Serial # 500632  500651 Lot # 62394012, Serial # 500652  500671 Lot # 62454338, Serial # 500692  500711 Lot # 62476761, Serial # 500712  500731 Lot # 62494048, Serial # 500732  500751 Lot # 62494086, Serial # 500752  500771 Lot # 62525837, Serial # 500772  500791 Lot # 62554526, Serial # 500792  500811 Lot # 62578715, Serial # 500812  500831 Lot # 62578759, Serial # 500832  500851 Lot # 62635778, Serial # 500852  500871
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
  • 제품 설명
    Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. || The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. || The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
  • Manufacturer
    Zimmer Surgical Inc

Manufacturer

Zimmer Surgical Inc
  • 제조사 주소
    Zimmer Surgical Inc, 200 W Ohio Ave, Dover OH 44622-9642
  • 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