Events

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pioneer Surgical Technology 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
    34922
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0872-06
  • 사례 시작날짜
    2006-03-03
  • 사례 출판 날짜
    2006-05-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44953
  • 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
    Screw, Fixation, Bone - Product Code HWC
  • 원인
    There may be an obstruction in the cannula that will prevent the guide wire from passing through it. the obstruction in the cannula can force the guidewire to advance further into the patient than intended.
  • 조치
    Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.

Device

Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-0...
  • 모델명 / 제조번호(시리얼번호)
    Lots 51198300, 51217200, 51234800, 51260000 and 51302600.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide.
  • 제품 설명
    Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50. Manufactured by Pioneer Surgical Technology, Marquette, MI; Distributed by Zimmer, Warsaw, IN.
  • Manufacturer
    Pioneer Surgical Technology

Manufacturer

Pioneer Surgical Technology
  • 제조사 주소
    Pioneer Surgical Technology, 375 River Park Cir, Marquette MI 49855-1781
  • Source
    USFDA