Events

Device Recall Pinnacle Cancellous Screw 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
    62764
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0569-2013
  • 사례 시작날짜
    2012-11-28
  • 사례 출판 날짜
    2012-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111672
  • 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, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • 원인
    Depuy orthopaedics, inc. is issuing a voluntary recall of ten lots of the pinnacle¿ cancellous screw due to an incorrect description on the label. the label description reads pinnacle cannulated screw and should read pinnacle cancellous screw.
  • 조치
    The firm, DePuy Orthopedics, Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated July 2012 to its customers via email and mail. The notice described the product, problem and actions to be taken. The customers were instructed to determine whether they would like to retain and use the product or return affected product to DePuy in Warsaw, IN, and to complete and return the Reconciliation forms to your DePuy Sales Representative or by fax to: 574-371-4939. DePuy sales representatives are expected to aid customers in returning of recalled products. For questions about recall information provided, please contact the Manager, Post-Market Surveillance, 574-372-7333 (M-F; 8 am - 5 pm EDT.)

Device

Device Recall Pinnacle Cancellous Screw
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
  • 제품 설명
    Pinnacle Cancellous Screw || Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. || PINNACLE¿ CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.
  • 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