Events

Stryker Torque Wrench 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Stryker Spine SAS 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
    16051
  • 사례 시작날짜
    2014-01-22
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Manufacturer previously initiated a lot specific recall (ref #15444) after reports received that the hex tip of the torque wrench of an identified lot number subset had been fracturing during final tightening.The establised cause for the fracture was due to grain boundary attack as a result of the heat treat process. since that time additional testing has continued and the manufacturer has made the decision to distribute a recall letter to all customers that have a procedure pack in their possession that may contain the affected product and inform them of the recall expansion. additionally the manufacturer has confirmed that the supplier will use a new heat treatment vendor for which there is a validated heat treatment process., 31/07/2015 - identified that lot 11e035 was not previous included in the recall letters associated with this recall. recall letter updated to include all affected lots and attached a list of all current locations.
  • 조치
    Product to be returned to supplier

Device

Stryker Torque Wrench
  • 모델명 / 제조번호(시리얼번호)
    Model: Xia 03807028, Xia 3 48237028, Mantis Redux 48287028, Affected: 092793, 098525, 11A957, 11E035, 11E039, 11E042, 11E045, 11E046, 11E047 , 123746, 127051 and R11E036
  • Manufacturer
    Stryker Spine SAS

Manufacturer

Stryker Spine SAS
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA