Events

SROM distal femoral cutting block guide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Depuy Orthopaedics, 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
    57245
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1389-2011
  • 사례 시작날짜
    2010-10-19
  • 사례 출판 날짜
    2011-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95655
  • 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 was notified that the hinge block femoral box guide cut being off alignment when using the s-rom distal femoral cutting block guide sz sml/x-sml pin holes to locate. the firm then found that the same issue was found int the med block size.
  • 조치
    The firm, DePuy, sent an "URGENT INFORMATION - DEVICE CORRECTION" email and letter dated October 19, 2010 to all customers. The notices described the product, problem and actions to be taken by the customers. The notices stated that: Depuy is issuing a device correction; however, the product may still be used; the devices do not need to be returned; the distributors were to provide a letter to clinicians that were using the device; the surgical technique will be revised in October 2010; the product will undergo a design change, and the recalled product will be traded out in December 2010 and January 2011. If you have any additional questions, please contact DePuy's Scientific Information office at 1-888-554-2482. On 3/4/2011, The firm sent out a revised URGENT DEVICE RECALL asking that all affected cutting guides be taken out of service immediately. Devices should be returned to DePuy and new cutting guides will be sent out within 2 weeks.

Device

SROM distal femoral cutting block guide
  • 모델명 / 제조번호(시리얼번호)
    C44AK4000, D1WL94000, DG9LA4000, DJ5EF4000, DJ5EV4000, DY6GB4000 and DP5WM4000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.
  • 제품 설명
    S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England. || The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • 제조사 주소
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA