Events

Device Recall Stryker Orthopaedics Restoration Gap Plate Screw 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
    52713
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2139-2009
  • 사례 시작날짜
    2009-06-26
  • 사례 출판 날짜
    2009-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83764
  • 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, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • 원인
    Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in astm standard for titanium surgical implants.
  • 조치
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Stryker Orthopaedics Restoration Gap Plate Screw
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 2080-0040; GAP PLATE SCREWS PTDMKE 27-Jun-2013 GAP PLATE SCREWS T0MMKE 01-Jul-2013 GAP PLATE SCREWS PT9MKE 02-Jul-2013 GAP PLATE SCREWS 34HMLE 09-Jul-2013 GAP PLATE SCREWS 34EMLE 14-Jul-2013 GAP PLATE SCREWS JKRMLE 23-Jul-2013 GAP PLATE SCREWS JKPMLE 23-Jul-2013 GAP PLATE SCREWS NL3MME 27-Aug-2013 GAP PLATE SCREWS NL6MME 27-Aug-2013 GAP PLATE SCREWS NL5MME 27-Aug-2013 GAP PLATE SCREWS NL4MME 28-Aug-2013 GAP PLATE SCREWS 7E4MNE 17-Sep-2013 GAP PLATE SCREWS 7E5MNE 17-Sep-2013 GAP PLATE SCREWS MERN50 05-Dec-2013 GAP PLATE SCREWS MERN4Y 05-Dec-2013 GAP PLATE SCREWS MET81P 18-Dec-2013 GAP PLATE SCREWS MET81T 18-Dec-2013 GAP PLATE SCREWS MET81V 18-Dec-2013 GAP PLATE SCREWS MET81R 22-Dec-2013 GAP PLATE SCREWS MET969 30-Dec-2013 GAP PLATE SCREWS MET967 30-Dec-2013 GAP PLATE SCREWS MET9H3 30-Dec-2013 GAP PLATE SCREWS MHA5LL 18-Jan-2014 GAP PLATE SCREWS MHA5LM 18-Jan-2014 GAP PLATE SCREWS MHA5LN 18-Jan-2014 GAP PLATE SCREWS MHA5LK 18-Jan-2014 GAP PLATE SCREWS MHA779 18-Jan-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Stryker Orthopaedics Restoration Gap Plate Screw; || Dia. 6.5 mm, Lnth 40 mm; || Made in USA, Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430
  • 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