Events

Device Recall Mini MaxLock Extreme Plating System Case and Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Orthohelix Surgical Designs 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
    59462
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3081-2011
  • 사례 시작날짜
    2011-07-06
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102838
  • 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
    Plate, fixation, bone - Product Code HRS
  • 원인
    The surgical tray does not meet our instruction for use (ifu) for dry time requirement.
  • 조치
    Orthohelix Surgical Designs Inc sent a RECALL NOTIFICATION letter dated July 6, 2011 and an UPDATED URGENT RECALL 2ND NOTIFICATION letter dated July 13, 2011 to all affected customers. The letter identified the recalled product, the problem, and the Field Correction actions to be taken. Customers were instructed to remove the blue rubber mat in the utility bay of the tray base immediately, tag the mat with the tray number, and return it to recalling firm immediately. The letter states once customers have removed the blue rubber mat from the tray base, they may continue to use the tray and system normally. No further actions or precautions are needed. Distributors were also asked to notify their customers of the recall. If you have any questions, please call 330-247-1444 or 330-247-1445.

Device

Device Recall Mini MaxLock Extreme Plating System Case and Tray
  • 모델명 / 제조번호(시리얼번호)
    Model Number(s): MXM-901; Tray codes affected: LAQ, LAV, LCL, LCN, LBZ, LCA, LBV, LCU, LAR, LBJ, LBT, LDE, LDG, LBL, LCD, LBI, LCI, LBQ, LCV, LBK, LBC, LCW, LCB, LDH, LBM, LCM, LCK, LDB, LBS, LCE, LDD, LDF, LAX, LDI, LAP, LBH, LBP, LAO, LBB, LBE, LBX, LCH, LAT, LAS, LCR, LDC, LAW, LCJ, LDJ, LCZ, LAU, LBF, LCQ, LBN, LCP, LCX, LBU, LBW, LBY, LCT, LCY, LAY, LAZ, LBA, LBD, LBG, LBO, LBR, LCC, LCF, LCG, LCS, LDA, LDM, LDN, LDO, LDP, LDQ, LDR, LDS, LDT, LDU & LDK.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Nationwide Distribution including the states of: AR, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI & WY.
  • 제품 설명
    Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, || Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. Surgical Case and Tray Delivery System used to house plating and screw orthopedic implant system and instrumentation.
  • Manufacturer
    Orthohelix Surgical Designs Inc

Manufacturer

Orthohelix Surgical Designs Inc
  • 제조사 주소
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA