Events

Device Recall Depuy Mitek Lupine Loop Plus Anchor w/Orthocord 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Mitek, Inc., a Johnson & Johnson Co. 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
    61088
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1165-2012
  • 사례 시작날짜
    2012-01-27
  • 사례 출판 날짜
    2012-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107272
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • 원인
    Lupine br anchor w/ orthocord may be assembled with an incorrect suture configuration and result in a loose repair.
  • 조치
    DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.

Device

Device Recall Depuy Mitek Lupine Loop Plus Anchor w/Orthocord
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 3254781 3259472 3259473 3263565 3265787 3273870 3274773 3275873 3276291 3278853 3280529 3285982 3286251 3291282 3292557 3294717 3300535 3303070 3303075 3303604 3307875 3309446 3313532 3314878 3315281 3318271 3319392 3320464 3324809 3328905 3331650 3332255 3339389 3340066 3356491 3357497 3361638 3368804 3372525 3374540 3375492 3378618 3380652 3382627 3385834 3386389 3389506 3392332 3393563 3394954 3401170 3401301 3403712 3404939 3406628 3410341 3412859 3413014 3414534 3414903 3417105 3418953 3424006 3424941 3430964 3431594 3432457 3432798 3437342 3441412 3447179 3449011 3449384 3451257 3453525 3454445 3458884 3472241 3473286 3474051 3487118 3488781 3489687 3491266 3492330 3498043 3508003 3509574 3513371 3514879 3516051 3519400 3522745 3524885 3529297 3532089 3533829 3539766 3545357 3545358 3549296 3551172 3551298 3557174 3557804 3558973 3562014 3565747 3570375
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
  • 제품 설명
    Depuy Mitek Lupine Loop Plus Anchor w/Orthocord || Catalog Number: 210708 || The Lupine Anchor System is indicated for use in soft tissue bone fixation.
  • Manufacturer
    DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufacturer

DePuy Mitek, Inc., a Johnson & Johnson Co.
  • 제조사 주소
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Dr, Raynham MA 02767
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA