Events

Device Recall Stryker Orthopaedics 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    75889
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1020-2017
  • 사례 시작날짜
    2016-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151592
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Reunion tsa peg alignment sound broke during surgery.
  • 조치
    Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated December 2, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 1360184/RA2016-112 Complete and sign the enclosed Business Reply Form and fax a copy to 855-261-3635 or email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. Customers with questions were instructed to call 201-831-6693.

Device

Device Recall Stryker Orthopaedics
  • 모델명 / 제조번호(시리얼번호)
    Catalog #5901-1038
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Reunion TSA Peg Alignment Sound || Catalog #5901-1038 || The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA