Events

Device Recall MIS (Minimally Invasive Surgery) Toolsteel Burs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. 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
    75819
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0869-2017
  • 사례 시작날짜
    2016-11-30
  • 사례 출판 날짜
    2016-12-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151388
  • 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
    Stryker instruments is voluntarily recalling specific lots of sterile mis toolsteel burs because the burs may exhibit signs of corrosion.
  • 조치
    The firm, Stryker Instruments, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 2016 to its Customers Overnight service, FedEx on November 30, 2016. The letter described the product, problems and actions to be taken. Stryker Sales Representatives and Stryker International will be notified via email. Customers are instructed to do the following: 1. Immediately review the Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many affected Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Burs. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of the notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to StrykerInstrumentsRecalls@stryker.com. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Recalled products will be destroyed, packaging will be defaced, opened and discarded. Product will be discarded. For questions regarding this recall, please contact Stryker Instruments: StrykerInstrumentsRecalls@stryker.com, or

Device

Device Recall MIS (Minimally Invasive Surgery) Toolsteel Burs
  • 모델명 / 제조번호(시리얼번호)
    Lot Number:16056017, Product Number: 8450-107-525
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
  • 제품 설명
    8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile || The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. || Each cutting accessory consists of: || " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. || " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA