Events

Surgical Bit 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
    63077
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0383-2013
  • 사례 시작날짜
    2012-04-10
  • 사례 출판 날짜
    2012-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112470
  • 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
    Bit, drill - Product Code HTW
  • 원인
    Linvatec corporation dba conmed linvatec in largo, fl is recalling the s8580, 8.0mm sentinel cannulated drill bit, lot numbers 322225 and 322226; and the s8585, 8.5mm sentinel cannulated drill bit, lot number 322287. recall was initiated due to the incorrect labeling on package.
  • 조치
    ConMed/Linvatec sent an Urgent Medical Device Recall Notificaiton letter via phone and FedEx on April 9, 2012 and again on May 11, 2012, to all affected customers. They also sent the same Notification on May 14, 2012, to international accounts. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete a reply formand fax it to 727-319-5701. Customers were also instructed to return all affected product to the firm. All returned product under this removal action will be identified, segregated and quarantined per firm procedures, etc. Customers with questions should contact Customers Service at Custserv@linvatec.com. For questions regarding this recall call 727-392-6464.

Device

Surgical Bit
  • 모델명 / 제조번호(시리얼번호)
    S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.
  • 제품 설명
    "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". || This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

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