Events

Device Recall Triathlon X3 Posterior Stabilized Tibial Insert 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
    50738
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1013-2009
  • 사례 시작날짜
    2008-12-18
  • 사례 출판 날짜
    2009-03-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76807
  • 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
    Knee Prosthesis Components - Product Code JWH
  • 원인
    Stryker orthopaedics became aware of a lot for lot mix-up between part numbers 5532-g-713, lot code lbd528 (triathlon x3 posterior stabilized tibial insert, size 7-13 mm) and part 5532-g-813, lot code lbd512 (triathlon x3 posterior stabilized tibial insert size 8-13 mm).
  • 조치
    Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.

Device

Device Recall Triathlon X3 Posterior Stabilized Tibial Insert
  • 모델명 / 제조번호(시리얼번호)
    Lot code LBD528 and Lot code LBD512.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution: FL and IL.
  • 제품 설명
    Triathlon X3 Posterior Stabilized Tibial Insert || Use with Triathlon PS Femoral Components. || Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; || Catalog number 5532-G-713, Catalog number 5532-G-813 || Stryker Orthopaedics
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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