Events

Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 20mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wright Medical Technology, 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
    69058
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2602-2014
  • 사례 시작날짜
    2014-07-30
  • 사례 출판 날짜
    2014-09-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129462
  • 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
    Plate, fixation, bone - Product Code HRS
  • 원인
    Plates manufactured from an incorrect raw material.
  • 조치
    Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

Device

Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 20mm
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1490004, 1490005, 1490199, 1490200, 1490201, 1490202, 1518483, 1519493, 1519494, 1519495, 1522021, 1522898, 1522899, 1522900, 1523735, 1523736, 1526519, 1526520, 1526521, 1538760, 1538761, 1539402, 1540715, 1540716, 1540717, 1542703, 1542704, 1542776, 1543491, 1543891
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
  • 제품 설명
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE || Orthopedic
  • Manufacturer
    Wright Medical Technology, Inc.

Manufacturer

Wright Medical Technology, Inc.
  • 제조사 주소
    Wright Medical Technology, Inc., 1023 Cherry Rd, Memphis TN 38117-5423
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA