Events

Device Recall DIGIT TRAP FINGER GRASPING DEVICE 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
    54701
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2250-2010
  • 사례 시작날짜
    2010-01-28
  • 사례 출판 날짜
    2010-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92978
  • 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
    Disposable Surgical Instrument - Product Code KDC
  • 원인
    This recall was due to the possibility that the products may have a breach in the poly-tyvek pouch that could potentially compromise the sterility of the contents.
  • 조치
    Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service department at 800-535-8536.

Device

Device Recall DIGIT TRAP FINGER GRASPING DEVICE
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 46718 27646 27651 46723 46721 46725 65281 65282 65286 65287 65285 65288 65284 65289 65283 65290 79999 72402 80005 72400 72387 72397 80002 72396 82263 80084 80083 80004 80001 82269 82268 82267 82264 80085 80086 80087 82260 83464 83356 83466 82271 83354 83351 83463 83465 83359 83358 83475 83473 83474 83476 83477 83470 82266 83469 83468 83467 83472 83471 82270 91993 89393 87332 89395 87330 87329 87328 87331 89392 91991 89394 91990 91989 89391 91994 91992 91996 91997 91995 94244 94242 95864 95865 94247 95866 95863 95860 94248 94246 95861 94245 95862 97811 97809 97812 97808 97810 95868 95858 95869 97814 100148 100151 100152 100150 100153 100147 97813 100149 105175 102411 102412 102414 102415 82272 105353 102416 102417 106093 106095 106092 105356 106094 106979 106978 106977 105355 107307 107308 107306 109531 107305 107309 109533 109534 107304 107302 107303 113326 116073 116072 116071 116070 116069 115111 115110 113324 117756 117755 119290 119289 119291 119292 119293 119294 121908 121909 121910 121915 123605 123601 121911 123603, and  121914.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, South Africa, and throughout the U.S.
  • 제품 설명
    REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. || Intended for use in small joint arthroscopic procedures.
  • 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