Events

Rejuvenate Modular Stems 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
    62456
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2090-2012
  • 사례 시작날짜
    2012-04-30
  • 사례 출판 날짜
    2012-07-26
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110699
  • 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
    Stryker has updated the instruction for use (ifu) (product correction)for the abgii modular and rejuvenate modular hip systems. this is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. on june 29, 2012, stryker has decided to remove the affected product from the field since there may be an.
  • 조치
    Stryker sent an "URGENT PRODUCT CORRECTION" letter dated April 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Product Correction Acknowledgment Form for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-831-5970 for questions regarding this notice. Stryker sent and "Urgent Update Product Recall" Letter dated January 3, 2013 to all affected customers. The new letter includes updated corrective actions for patients. Another letter was sent out on 7/25/2014.

Device

Rejuvenate Modular Stems
  • 모델명 / 제조번호(시리얼번호)
    510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Rejuvenate Modular Stems || Stryker Ireland Carrigtwohill Industrial Estate || Carrigtwohill County Cork, Ireland || Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. || Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
  • 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