Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Spine, 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
    56894
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0818-2011
  • 사례 시작날짜
    2010-10-02
  • 사례 출판 날짜
    2010-12-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-04-15
  • 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
    Tray, Surgical - Product Code LRP
  • 원인
    The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy.
  • 조치
    Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.

Device

  • 모델명 / 제조번호(시리얼번호)
    Not lot coded
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.
  • 제품 설명
    Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile || Product Code: 2883-90-420 || The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
  • Manufacturer

Manufacturer

  • 제조사 주소
    DePuy Spine, Inc., 325 Paramount Drive, Raynham MA 02767
  • 제조사 모회사 (2017)
  • Source
    USFDA