Device Recall PopLok Punch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Linvatec Corp. dba ConMed Linvatec 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
    62665
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2151-2012
  • 사례 시작날짜
    2012-07-06
  • 사례 출판 날짜
    2012-08-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Conmed linvatec recalled one lot of their poplok bone punch 3.5mm because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
  • 조치
    The recall is being conducted to the end user level. ConMed Linvatec Urgent Medical Device Recall Notifications were sent by FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with the reason for the recall and health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return all affected product to ConMed Linvatec and respond using a Reply Form, even if there is no affected product available. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 318455
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US and Korea.
  • 제품 설명
    PopLok Punch labeled in part: || "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" || Intended Use: Bone Punch.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • 제조사 모회사 (2017)
  • Source
    USFDA