Events

Device Recall Origen DBM with Bioactive Glass 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nanotherapeutics, 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
    60335
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0347-2012
  • 사례 시작날짜
    2011-03-10
  • 사례 출판 날짜
    2011-12-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105049
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • 원인
    On 03/10/2011 nanotherapeutics inc, alachua, fl initiated a recall of their origen dbm with bioactive glass catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). the same product is also distributed as nanofuse dbm catalog # nan109-02 (2cc) nan109-05 (5cc) and nan109-10(10cc). the products were manufactured without an approved 510k. direct accounts were notified of the recall on 04/08/2011.
  • 조치
    Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached. Recall Instructions: Immediately examine inventory and quarantine product subject to recall. Return all quarantined product subject to recall to: Nanotherapeutics, Inc. Attn: Receiving Department 13859 Progress Blvd, Suite 300 Alachua, Florida 32615 For questions call 386-462-9663

Device

Device Recall Origen DBM with Bioactive Glass
  • 모델명 / 제조번호(시리얼번호)
    Catalog # NAN109-02, Lot #: 074349P.  Catalog # NAN109-05, Lot #: 073995PA, 077870PB.  Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • 제품 설명
    Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" || Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" || NanoFUSE DBM Catalog #: || NAN109-02 (2cc size) || NAN109-05 (5cc size) || NAN109-10(10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc

Manufacturer

Nanotherapeutics, Inc
  • 제조사 주소
    Nanotherapeutics, Inc, 13859 Progress Blvd Ste 300, Alachua FL 32615-9403
  • 제조사 모회사 (2017)
    Nanotherapeutics, Inc
  • Source
    USFDA