Events

Synthes 5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes (USA) Products 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
    72134
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0134-2016
  • 사례 시작날짜
    2015-09-04
  • 사례 출판 날짜
    2015-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139928
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • 원인
    This product was produced using a finishing process not identified as part of the manufacturing specification. the process used with the lots subject to this recall was a bead blast process. (bead blasting vs. shot peened).
  • 조치
    An Urgent Notice: Medical Device Recall, dated September 4, 2015, was sent to end users to alert them about the issue and possible risk to patients. Customers were requested to follow the actions to be taken for if they have affected product or not; complete the response form, and return affected product. Customers can call 610-719-5450 or a local Synthes Sales Consultant with any questions.

Device

Synthes 5.0mm Unit Stainless Steel Rods for the Synthes Small Stature USS
  • 모델명 / 제조번호(시리얼번호)
    Part numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278 lot numbers: 4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595; 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489; 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224; 4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619;  4729956; 4923674; 4987825; 4987780; 5066363; 4729958; 4923615; 4987826; 4987781; 5066364; 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854; 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330; 4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451; 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; and 5153851.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, || 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, || 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, || 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • 제조사 주소
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA