Events

Device Recall SROM Noiles Rotating Hinge Femur with Pin 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
    67627
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1203-2014
  • 사례 시작날짜
    2014-02-24
  • 사례 출판 날짜
    2014-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-03-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125862
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • 원인
    Depuy orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for s-rom¿ noiles rotating hinge femur with pin devices. the outer carton and shrink wrap are intact. a package redesign is underway to resolve this issue. s-rom noiles rotating hinge femur with pin devices will remain in us distributors inventory during the.
  • 조치
    DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to DePuy. Product related questions should be addressed to DePuy Orthopaedics, .Sales Consultant. Clinical questions should be addressed to DePuy Scientific Information Office 1-888-554-2482; recall questions to 574-371-4917.

Device

Device Recall SROM Noiles Rotating Hinge Femur with Pin
  • 모델명 / 제조번호(시리얼번호)
    249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447, 456738, 456740, 466369, 466370, 466371, 058401LA, 137401LA, D2WBG4, D37FW4, D37GP4, DV6LY4, DY5EC4, DY5ED4, E1VHM4, E3SDW4, E6CE94, E82E14, EA8EH4, EF5BS4, EJ6G34, EW6HT4, FJ3D14, FJ3D24, and FJ3DY4
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.
  • 제품 설명
    REF 623401 L || S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R || Qty 1 || The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
  • 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