Events

Device Recall DePuy Custom Implant Devices 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
    62766
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2217-2012
  • 사례 시작날짜
    2012-07-31
  • 사례 출판 날짜
    2012-08-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111674
  • 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
    Subtalar joint-crossing uncemented semi-constrained ankle prosthesis - Product Code OOM
  • 원인
    In connection with a warning letter received from the u.S. food & drug administration on december 9, 2011, depuy orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from depuy orthopaedics, but not implanted. depuy orthopaedics received a warning letter from the fda on december 9, 2011 regarding custom device implants. depuy orthopaedics has discontinue.
  • 조치
    DePuy sent a written communication letter dated July 31, 2012 to all consignees. The communication to the hospital customers who received the devices includes a "Surgeon Letter" with instructions to provide the surgeon letter to the Surgeon users. All DePuy Distributors will be notified via email. The sales representatives notified the hospital and surgeons either by mail or in person with a written communication. The letters identified the affected product, problem and actions to be taken. Customers are instructed to complete the attached Roponse form and return to fax number 574-371-4939 or email: kseppa@its.jnj.com. The sales representatives are expected to aid customers in returning of unused Custom Device implants, if needed. The devices can be returned through the normal DePuy Returns process, to attention of "Returns" and marked "Custom Returns" on the outside of the box. Questions Regarding the Removal Questions regarding the removal may be directed to the following DePuy representatives  -Questions about removal information provided: Katie Seppa, Manager of Post-Market Surveillance, 574-372-7333 (M-F; 8 am  5 pm EDT) -Clinical related questions from surgeons: Direct to DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am-5 pm EDT)

Device

Device Recall DePuy Custom Implant Devices
  • 모델명 / 제조번호(시리얼번호)
  • 유통
    US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • 제품 설명
    DePuy Custom Implant Devices || Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product || Product Usage: || Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA