Events

Steinmann Pin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MicroAire Surgical Instruments, LLC 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
    66029
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2158-2013
  • 사례 시작날짜
    2013-08-12
  • 사례 출판 날짜
    2013-09-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121296
  • 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
    Pin, fixation, smooth - Product Code HTY
  • 원인
    A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility.
  • 조치
    MicroAire Surgical LLC sent an Urgent Medical Device Recall letter dated August 12, 2013, to all affected customers. The letter advised consignees recover and quarantine the affected product so that it does not make it into the surgical process. Customers were instructed to either return affected product to MicroAire for inspection or they could inspect the product for the defect by looking at the seal area on the inside sterile package (short non-chevron side). The recalling firm further advised distributors to contact all of their customers to recover and quarantine the product so that it does not make it into the surgical process. Customers with questions were instructed to call 434-975-8370. For questions regarding this recall call 434-975-8370.

Device

Steinmann Pin
  • 모델명 / 제조번호(시리얼번호)
    Product # Lot Number  1620-109 0213216244  1620-109 0213216804  1620-109 0313217447  1620-109 0413219296  1620-109 0413219479  1620-109 0613222208  1620-509 0213216077  1620-509 0213216598  1620-509 0213216740  1620-509 0313217912  1620-509 0313217980  1620-509 0413219446  1620-509 0413219514  1620-509 0513220340  1620-509 0613222209  1620-509 0613222677  1620-509 0613222950  1620-609 0213216021  1620-609 0213216987  1620-609 0313218036  1620-609 0413218860  1620-709 0313217801  1620-709 0413218861  1620-709 0513220659  1620-709 0613222204  1620-709 0613222465  1620-709 0613223531  1620-709 0713224375  1624-109 0213216721  1624-109 0313218583  1624-109 0413219836  1624-109 0413219934  1624-109 0613222761  1624-109 0713223840  1624-509 0213216018  1624-509 0213217203  1624-509 0313217576  1624-509 0313218461  1624-509 0413219480  1624-509T 0213215841  1628-509 0213217207  1628-509 0413219845  1628-509 0513220335  1628-509 0513220422  1628-509 0613222210  1632-509 0213216079  1632-509 0213216820  1632-509 0313218668  1632-509 0313218715  1632-509 0513220951  1632-509 0613222467  1632-509 0613223364  1632-609 0413219600  1636-509 0313218458  1636-509 0413218937  1640-509 0213216975  1640-509 0213216985  1640-509 0313217640  1640-509 0313217911  1640-509 0413219741  1640-509 0413219936  1640-509 0513220770  1648-509 0213216078  1648-509T 0213216803  1648-609 0213216295  1648-609 0513221947  1648-609T 0413220144
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Australia, Ireland, Canada, Netherlands, Sweden, Japan, and United Kingdom.
  • 제품 설명
    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** || Models: || 1620-109 1636-509 || 1620-509 1640-509 || 1620-609 1648-509 || 1620-709 1648-509T || 1624-109 1648-609 || 1624-509 1648-609T || 1624-509T || 1628-509 || 1632-509 || 1632-609 || A smooth or threaded wire / pin that may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
    MicroAire Surgical Instruments, LLC

Manufacturer

MicroAire Surgical Instruments, LLC
  • 제조사 주소
    MicroAire Surgical Instruments, LLC, 3590 Grand Forks Blvd, Charlottesville VA 22911-9001
  • 제조사 모회사 (2017)
    Colson Associates Inc.
  • Source
    USFDA