Device Recall Gemlock 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Dental 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
    70304
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1115-2015
  • 사례 시작날짜
    2015-01-22
  • 사례 출판 날짜
    2015-02-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-08-03
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • 원인
    The gemlock long hex driver may not fit into the fixture mount transfer (fmt) or the internal hex of the implant.
  • 조치
    An Urgent Device Recall Notice was sent on 1/22/15 to their domestic and foreign customers who purchased the Gemlock Long Hex Driver. The letter informs the customers of the problems identified, risks, and the actions to be taken. Customers are instructed to review the notice and check their inventory for the affected units. All affected product is to be immediately quarantined and removed from service. Customers are to contact Simmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and set up return of the products. Customers should complete the attached Business Reply Form and fax it to (574) 372-4265 or e-mail to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, Mon-Fri, 7 am-5pm (Pacific). Zimmer Dental is expanding the recall to include 1 additional lot for catalog no.TSVKIT. Zimmer Dental plans to inform an amended customer notification letter to their US and foreign consignees. The letter will go out to customers on 4/20/15 to inform them of the expanded lot.

Device

  • 모델명 / 제조번호(시리얼번호)
    Etched Lot No. 62699693 & 62735177. Lot Number on Label: 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456, and 62773158.  Expanded Lot No. 62728173.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain
  • 제품 설명
    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. || Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA