Device Recall Persona Anterior Referencing Sizer with Locking Boom 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
    70676
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1360-2015
  • 사례 시작날짜
    2015-03-10
  • 사례 출판 날짜
    2015-04-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, inc is voluntarily recalling 22 lots of persona¿ anterior referencing sizer with locking boom, part number 42-5099-088-10. devices are being removed from distribution due to nonconforming to print specifications.
  • 조치
    Zimmer sent an Urgent Medical device recall letter to all customers on March 10, 2015, via letter and email. The letter identified the product, the problem, and the action to be taken by the customer. Affected units will be inspected. Units that fail inspection will be physically destroyed/scrapped. Units that pass inspection will be re-etched and redistributed. If after reviewing this notification customers have further questions or concerns they were instructed to call the customer call center at 1-877-946-2761. Hours of operation are Monday through Friday, 8:00 a.m. through 5:00 p.m. EST. For questions regarding this recall call 574-372-4487.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
  • 제품 설명
    Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom || The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
  • 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