Events

Empowr PS Knee System Box Cut Guide 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    75645
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0766-2017
  • 사례 시작날짜
    2016-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150980
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    It has been discovered that during empowr ps total knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.
  • 조치
    DJO Global sent an Urgent Field Safety Notice dated September 19, 2016, to all affected customers. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device. Customers were instructed to become familiar with the new surgical techniques and notify all of their applicable users of the revised methods. Customers were also instructed to sign the Acknowledgement and Receipt Form. Customers with questions were advised to call 760-734-3551. For questions regarding this recall call 512-832-6302.

Device

Empowr PS Knee System Box Cut Guide
  • 모델명 / 제조번호(시리얼번호)
    202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Empowr PS Knee System Box Cut Guide || The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • 제조사 모회사 (2017)
    The Blackstone Group LP
  • Source
    USFDA