Events

Device Recall Specialist 2 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
    63973
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0971-2013
  • 사례 시작날짜
    2013-02-05
  • 사례 출판 날짜
    2013-03-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116519
  • 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
    Potential for the im rod to break, leaving fragments in the patient. surgical techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
  • 조치
    DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email kseppa@its.jnj.com Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.

Device

Device Recall Specialist 2
  • 모델명 / 제조번호(시리얼번호)
    Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54  C4GCC4  C4GBT4  C52F74 H1108 C52GV4 H1208 C52GL4  C67N14  C98CS4 H0109 C98BF4  DE5P34 H0309 DE5RP4  DF4H44  DG9LK4 H0409 DG9L64  DJ5E34  DK3E34 H0509 DK3FE4  EB5FV4 H0210 D95AN4  EB5GH4 H0310 EC9JY4  EF4DJ4  EJ7AP4 H0410 ES2G64 H0510 EJ7A34  ES2HA4 H0610 ES2HY4 H0710 EX5L44  EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4  FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide.
  • 제품 설명
    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: || Sigma HP Instruments Classic Surgical Technique,0612-89-510 || Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 || Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 || PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 || Product Usage: || The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.
  • 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