Device Recall Left Locking 2st MTP/MPJ Combo Fusion Plate 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Acumed 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
    48453
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2116-2008
  • 사례 시작날짜
    2008-02-14
  • 사례 출판 날짜
    2008-09-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-02-03
  • 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
    Bone Fixation - Product Code HWC
  • 원인
    Product sterility may be compromised.
  • 조치
    The firm issued four separate Urgent Notification: Product Removal were issued by the firm on 2-14-2008, 2-20-2008, 2-26-2008, and 3-25-2008 for the issue of poorly sealed sterile pouches. The notifications were reportedly sent by either FAX or e-mail. The firm explained the issue and requested customers to return the specified products. On 7/16/08, the firm issued a second recall notification to their customers. This letter informed the customer of the recall, listed the products affected, stated the reason for the recall, tells customers, "return existing inventories of the recalled products to Acumed... If you further distributed this product, please notify those customers/consignees of this recall. This recall is to be extended to the user level." The letter includes an effectiveness form to be filled out by the customer and returned to Acumed.

Device

  • 모델명 / 제조번호(시리얼번호)
    Work order number/Lot: W58123 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution ---- USA including states of WA, NE, NC, UT, FL, CA, OR, TX, NY, IL, OH, MT, and Puerto Rico, and countries of United Kingdom, Australia, and Greece.
  • 제품 설명
    Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".
  • Manufacturer

Manufacturer

  • 제조사 주소
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • 제조사 모회사 (2017)
  • Source
    USFDA