Events

Device Recall Cervical Spine Locking Plate (CSLP) System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes (USA) Products LLC 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
    73549
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1524-2016
  • 사례 시작날짜
    2016-01-06
  • 사례 출판 날짜
    2016-04-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144448
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 원인
    Depuy synthes is initiating a voluntary medical device recall of lot # 9666776 and 9671879 of cancellous and cortex 4.0 mm screws, which are a part of the cervical spine locking plate (cslp) system due to discovery of a single lot of 450.136 screws (4mm cancellous self tapping screw, length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm cortex standard screw, length 16 mm, lot 9671879).
  • 조치
    DePuy Synthesis sent an Urgent Notice Medical Device Recall letter dated January 6, 2016 to customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers to complete and return the attached Verification Section (page 3 of the letter). For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Device Recall Cervical Spine Locking Plate (CSLP) System
  • 모델명 / 제조번호(시리얼번호)
    Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
  • 제품 설명
    Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • 제조사 주소
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA