Events

Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences 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
    74224
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2084-2016
  • 사례 시작날짜
    2016-05-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146870
  • 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
    Passer, wire, orthopedic - Product Code HXI
  • 원인
    The affected k-wires do not meet specification requirements. specifically, a) k-wires were made of 316lvm stainless steel instead of 304 stainless steel. b) k-wires have passivated surface finish instead of electro-polish surface finish. c) k-wires have incorrect length and diameter.
  • 조치
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.

Device

Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm
  • 모델명 / 제조번호(시리얼번호)
    Lot 237830TE
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
  • 제품 설명
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System || The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.