D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Pty Ltd 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
    RC-2017-RN-00925-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-09
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Smith & nephew has identified that a number of devices are affected due to a labelling error. the expiration dates printed on the labels are incorrect; the dates shown are after the actual expiration date of the sterilised package.
  • 조치
    Smith & Nephew is requesting customers: 1.Immediately locate and quarantine affected devices; 2.If any of the recalled products could have been transferred from your facility to another hospital, provide copies of this notice to all users informing them of the recall; 3.Complete,sign and return the supplied Recall Acknowledgement Form with the number of affected devices you have to return. Complete the form even if you have no products to return. 4.The acknowledgement form may be returned by email to RegulatoryAffairs.ANZ@smith-nephew.com or by fax on 1800 671 000 (Toll Free) 5.If you have affected product to return, Smith & Nephew representatives will be in contact with you once you have returned the Acknowledgement Form to arrange for affected products to be returned. 6.New unaffected replacement devices will be provided to you once Smith & Nephew have received your response.

Device

  • 모델명 / 제조번호(시리얼번호)
    D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-TappingModel Number: 74692412Batch Number: 15JM07539Expiry: September 2017ARTG Number: 104369
  • Manufacturer

Manufacturer