Events

Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 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-2016-RN-00979-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00979-1
  • 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
    It was identified that the specified lots of the locking screws stardrive ø 2.4 mm, self-tapping, length 12 mm, tan can break between the head and the shaft. this resulted from the neck feature being too close to the stardrive feature leaving a thin wall between the neck and drive. in the event that the non-conforming screw should separate between the head and the shaft during insertion or removal, a surgical delay may occur as the surgeon attempts to remove the shaft or fragment from the bone. removal of fragments can result in bone damage. additionally, a protruding fragment can lead to adverse tissue reaction or soft tissue irritation.
  • 조치
    Johnson &Johnson; Medical (JJM) is advising customers to identify, quarantine and return all unpackaged Locking Screws Stardrive Ø 2.4 mm, self-tapping, length12 mm, TAN in kits along with any screws still in the original packaging with the affected part and lot number. JJM Customer Service will organise replacement products for the returned stock

Device

Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orth...
  • 모델명 / 제조번호(시리얼번호)
    Locking Screws Stardrive Ø 2.4 mm, Self-Tapping, Length 12 mm, Titanium-Alloy-Niobium Alloy (Orthopaedic bone screw)Part Number: 412.812Lot Numbers: 9744302, 9946065Supplied as part of following systems: LCP Distal Radius System 2.4LCP Compact Hand 2.4LCP Compact Foot 2.42.4/2.7 mm Locking Tarsal PlatesARTG number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes