Device Recall Novation Crown Cup Connection GXL Neutral Liners 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Exactech, Inc. 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
    64028
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0787-2013
  • 사례 시작날짜
    2012-11-05
  • 사례 출판 날짜
    2013-02-05
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-12-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 원인
    Recall of novation crown cup connection gxl neutral liners catalog no. (130-32-53) and novation crown cup connection gxl + 5mm lateralized liners catalog no. (136-32-53). exactech discovered the device labeling was inadvertently transposed.
  • 조치
    Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of TN, FL, VA, WA and NV.
  • 제품 설명
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. || Exactech Hip Systems are indicated for use in surgery for hip replacement.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • 제조사 모회사 (2017)
  • Source
    USFDA