Device Recall Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control 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
    55157
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0072-2011
  • 사례 시작날짜
    2010-03-19
  • 사례 출판 날짜
    2010-10-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-01-12
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • 원인
    The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.
  • 조치
    The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all product replaced by 4/30/2010. If there are any questions or additional info needed, consignees should contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.

Device

  • 모델명 / 제조번호(시리얼번호)
    61255960, 61286739, 61293344, 61297228, 61301146, 61303916, 61321619, 61341496, 61341497, 61351886, 61361912, 61361919, 61369266, 61371666, 61371667, 61387139, 61396637 and 61413131.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.
  • 제품 설명
    Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN. || Used to mate the inserter with the shell implant.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA