Events

Device Recall Universal Spinal System Lamina Hooks 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
    62324
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2054-2012
  • 사례 시작날짜
    2012-05-31
  • 사례 출판 날짜
    2012-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110226
  • 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
    Uss lamina hooks, medium, right are being recalled because the hooks are etched with the wrong part number - 498.321 (lamina hook, medium, left). the lamina hooks should be etched with part number 498.320 (lamina hook, medium, right).
  • 조치
    SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: FieldAction@synthes.com. For any questions please call 610-719-5450.

Device

Device Recall Universal Spinal System Lamina Hooks
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 498.321, lot/serial #6876785
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
  • 제품 설명
    Universal Spinal System Lamina Hooks || Synthes Medium TI Lamina Hook - Right || 498.320 || Non sterile || LOT 6876785 || Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
  • 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