Events

Device Recall Synthes Matrix System T1 Matrix Locking Cap 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA (HQ), Inc. 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
    59290
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3207-2011
  • 사례 시작날짜
    2011-03-11
  • 사례 출판 날짜
    2011-09-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102135
  • 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, for degenerative disc disease - Product Code NKB
  • 원인
    Labeling correction -- the locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). this poses a potential risk of significant prolongation of or time.
  • 조치
    The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Consultant.

Device

Device Recall Synthes Matrix System T1 Matrix Locking Cap
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI.
  • 제품 설명
    Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. || Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
  • Manufacturer
    Synthes USA (HQ), Inc.

Manufacturer

Synthes USA (HQ), Inc.
  • 제조사 주소
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA