Events

Device Recall Accolade TMZF Plus Hip Stem 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
    58455
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2557-2011
  • 사례 시작날짜
    2011-03-01
  • 사례 출판 날짜
    2011-06-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99392
  • 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 ISL
  • 원인
    Accolade tmzf plus hip stems are being recalled due to grit blast media which was observed in the drive hole.
  • 조치
    Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to: Contact the hospitals in their territory that have the affected product to arrange return of the product. Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430. Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words "Product Recall." For any questions call (201) 972-2100.

Device

Device Recall Accolade TMZF Plus Hip Stem
  • 모델명 / 제조번호(시리얼번호)
    Catalog @ 3020-0537 Accolated TMZF Hip Stem # 5 Lot #31390203 8 units CAtalog #6020-3535 Accolade 132 Size 3.5 Lot #31446602R 0 units  CAtalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Lot #31515703 10 units Catalog # 6021-0335 Accolade Plus TMZF Hipe Stem #3 Lot 31586402 10 units Catalog #3021-0435 Accolade TMZF Hipe STem #4 31597205 1 unit CAtalog # 6021-0435 Accolade Plus TMZF Hipe STem #4 Lot #31597206 4 units Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Lot #31486505 10 units Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 Lot #31850001 1 unit
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Accolade TMZF Plus Hip Stem: || Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 || Catalog #6020-3535 Accolade 132 Size 3.5 || Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 || Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 || Catalog #3021-0435 Accolade TMZF Hip Stem #4 || Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 || Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 || Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 || K994366; k023105; K032300 || Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland || The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
  • 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