Events

Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System. 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
    79335
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1216-2018
  • 사례 시작날짜
    2017-10-16
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162049
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • 원인
    Stryker instruments and stryker leibinger gmbh & co. kg are voluntarily recalling certain serial numbers thoracic pedicle feelers that are used in conjunction with the stryker¿ navigation system because the settings on the machine were higher than intended. this change led to increased energy directed onto the tip of the thoracic pedicle feeler which caused material degradation where the laser marks exist. there is the potential for the tip of the thoracic pedicle feeler to break.
  • 조치
    US customers will be notified via FedEx overnight. US Sales Representatives will be notified via email. International entities will be notified via an internal notification system. International customers will be notified per local regulations/procedures. Customer Instructions: Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage for affected equipment. Quarantine and discontinue use of any affected Thoracic Pedicle Feelers. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you don't have any affected product on hand. 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 Notification and the attached BRF to all affected locations. Please indicate each location on the BRF. 5. If the BRF for your facility indicates that recalled product is currently on hand, we will contact you to arrange for the return of the product for repair/replacement. If discontinuing use of the specific Thoracic Pedicle Feeler(s) listed will cause disruption at your facility. For further questions, please call (269) 323-7700.

Device

Thoracic Pedicle Feeler instrument is intended for use with the Stryker Navigation System.
  • 모델명 / 제조번호(시리얼번호)
    Serial Number(s) Affected: 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10904, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10917, 10919, 10920, 10921, 10922, 10923, 10925, 10926, 10927, 10928. Product Code (UDI): (01)04546540503824
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International , US and US Govt.
  • 제품 설명
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of || the navigation software and creation of a pathway into the pedicle. The instrument has three || types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The || Pedicle Feeler is laser marked in 10 mm intervals to help indicate the depth in which the feeler || tip has been inserted into the pedicle. Next to the navigational information, these depth || indicators on the feeler tip are also helpful in determining the appropriate pedicle screw length.
  • 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