Device Recall Titanium Single Vector Distractor Body and Proximal Foot Plate 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
    74419
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2581-2016
  • 사례 시작날짜
    2016-05-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-12-13
  • 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
    External mandibular fixator and/or distractor - Product Code MQN
  • 원인
    Depuy synthes is voluntarily initiating a recall due to a possibility the fastener on the titanium single vector distractor body may become prematurely separated from the proximal foot plate.
  • 조치
    The firm, DePuy Synthes, mailed out an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 5/23/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately take the following actions: If you DO have any of the identified devices call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section (page 3 of the letter) indicating the number of devices that were found and return the Verification Section (page 3 of the letter) with the product to the following: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132, by fax 844-449-8498 or scan/email: Synthes8096@stericycle.com., and complete the Verification section even if you DO NOT have the identified product. Note: If the Verification Section is answered on behalf of more than one facility and/or individual clearly indicate the name and address of the facility and/or individual. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part # 487.962, Lot # A4JY080; 4042146; 4042147; 4365410; 4548558; 4664392; 5041113; 5041114; 5041162; 5071337; 5229307; 5414447; 5414448; 5414449; 5422905; 5621082; 5621083; 5621088; 5696010; 6164423; 6164425; 6164555; 6171239; 6171240; 6397761; 7537258; 7927945, mfg date 09JUN1999 -30JUN2015, exp date 22MAR2020-30JUN2035
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
  • 제품 설명
    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 || The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
  • Manufacturer

Manufacturer

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