Events

Triathlon Tibial Baseplate 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
    53427
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2334-2010
  • 사례 시작날짜
    2009-09-01
  • 사례 출판 날짜
    2010-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85487
  • 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
    A lot for lot mix up occurred between the triathlon total knee system primary tibial baseplate # 4 cemented, catalog # 5520-b-400, lot sh8nt and the #2 cemented, catalog # 5520-b-200, lot sh7rp.
  • 조치
    The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words "PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice. If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.

Device

Triathlon Tibial Baseplate
  • 모델명 / 제조번호(시리얼번호)
    # 4 - Catalog Number: 5520-B-400, Lot code: SH8NT; # 2 - Catalog Number: 5520-B-200, Lot Code SH7RP.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: AL, AZ, CA, MT, NJ and TX.
  • 제품 설명
    Triathlon Total Knee System Primary Tibial Baseplate; || Sterile, Made in Ireland. || Howmedica Osteonics || 325 Corporate Drive || Mahwah, NJ 07430 || The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surf ace of the patella is required, the Duracon patellar components are compatible with the Triathlon components). The Triathlon PS Total Knee System is intended to be used in situation where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene patellare components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously release Triathlon PS Femoral component in situation where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee system is intended to accommodate the posterior cruciate ligament (PCL) if it is present.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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