Events

Device Recall PROFEMUR(R) R RASP HANDLE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MicroPort Orthopedics 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
    75888
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0943-2017
  • 사례 시작날짜
    2016-11-17
  • 사례 출판 날짜
    2017-01-03
  • 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=151591
  • 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
    The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. the broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
  • 조치
    MicroPort Orthopedics sent an Voluntary Device Product Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the enclosed form even if they do not have any affected product to return. Return the completed form by fax to 1-901-451-6032 or by email to PostMarket@ortho.microport.com. Attempt #1 for acknowledgment will be made by email. For questions regarding this recall call 901-867-4318.

Device

Device Recall PROFEMUR(R) R RASP HANDLE
  • 모델명 / 제조번호(시리얼번호)
    Lot Number US100122
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution to Spain, China, and Italy
  • 제품 설명
    PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN || Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
  • Manufacturer
    MicroPort Orthopedics Inc.

Manufacturer

MicroPort Orthopedics Inc.