Events

Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    31985
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0241-06
  • 사례 시작날짜
    2004-11-22
  • 사례 출판 날짜
    2005-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-10-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38869
  • 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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • 원인
    The gamma nail may have been manufactured with an incorrect lag screw hole angulation. catalog number 3225-0360s, lot code k949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. catalog number 3220-0320s, lot code k949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
  • 조치
    Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.

Device

Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
  • 모델명 / 제조번호(시리얼번호)
    Catalog 3220-0320S Lot K949408  3225-0360S, lot code K949396
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
  • 제품 설명
    Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA