Events

Device Recall DRILOK THREADED CANNULA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 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
    79978
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2057-2018
  • 사례 시작날짜
    2017-12-21
  • 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=164124
  • 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
    Surgical cannulaes & depth gauge kit for athroscopic pocedures - Product Code PPR
  • 원인
    Inadvertent shipment of expired units.
  • 조치
    The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 12/27/2017 to its customers via mail on about 12/28/2017. Customers were initially notified via phone on 12/21/2017 and 12/22/2017. The letter described the product, problem and actions to be taken. The customers were instructed to inform those individuals in the organization who need to be aware of the recall; examine stock for affected devices; quarantine and discontinue use of recalled device; complete and return the Business Reply Form to Stryker Endoscopy via fax (408-855-6314) or email (endorecall@stryker.com), and if affected product is on hand segregate it and contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). If you have any questions, contact Director of Regulatory Affairs and Clinical Science at 408-754-2664 or email: to endorecall@stryker.com.

Device

Device Recall DRILOK THREADED CANNULA
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 14239AG2, UPC 07613327055795.  The expiration date marked on the box is August 2018, but it should be August 2016.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution to Massachusetts only..
  • 제품 설명
    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. || The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • 제조사 주소
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA