Device Recall Stryker 10.5MM X 10.7MM FLUTED DRUM, Super Long 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
    57505
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1237-2011
  • 사례 시작날짜
    2010-11-30
  • 사례 출판 날짜
    2011-02-14
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • 원인
    Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
  • 조치
    The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or kathleen.kelly.smith@stryker.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number 5190020105; Lots 9077017, 10155017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
  • 제품 설명
    Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. || These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
  • Manufacturer

Manufacturer

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