Events

Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Division of Stryker Corporation 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
    59057
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2794-2011
  • 사례 시작날짜
    2011-06-13
  • 사례 출판 날짜
    2011-07-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100967
  • 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
    Blade, saw, general, &, plastic surgery, surgical - Product Code GFA
  • 원인
    Recalled device was packaged with the incorrect angled blade. the labeling indicates a 12 degree angle but the product has a 40 degree angle.
  • 조치
    Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.

Device

Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE
  • 모델명 / 제조번호(시리얼번호)
    Lot number 10265CG2, Part number 5290-744-100
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
  • 제품 설명
    Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY || For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA