Events

Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter 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
    53858
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0529-2010
  • 사례 시작날짜
    2009-11-11
  • 사례 출판 날짜
    2009-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86691
  • 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
    Patella Cutter - Product Code HTS
  • 원인
    Disposable patella cutters - 30 mm (catalog number 8000-0030, lot v31257001) were packaged and labeled as 33 mm disposable patella cutters (catalog number 8000-0033, lot v31257001 and vice versa.
  • 조치
    An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

Device

Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 8000-0033; Lot code V31257001.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
  • 제품 설명
    Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; || Stainless Steel, Disposable; || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || 33 mm size, One single unit to a package. || Note: The 30 mm instruments were not distributed. || The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
  • 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