Events

Persona Stemmed Tibial Provisional Size H Right 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    79991
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1806-2018
  • 사례 시작날짜
    2017-08-07
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164143
  • 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
    There is a potential for intermittent cracks in the raw material batch used to produce the affected products. the cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
  • 조치
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL)  LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form and Attachment 3  Certificate of Decontamination to Zimmer Biomet. a. For each return, send a copy of Attachment 1 and Attachment 2 to corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen

Device

Persona Stemmed Tibial Provisional Size H Right
  • 모델명 / 제조번호(시리얼번호)
    Lot 63683139, UDI (01)00889024246942(10)63683139;  Lot 63613121, UDI (01)00889024246942(10)63613121
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
  • 제품 설명
    Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 || For use during orthopaedic surgery for implantation of a prosthesis.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, 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