Device Recall Endotec TMJ Components

  • 모델명 / 제조번호(시리얼번호)
    Lot No: 09110215NN373 09110216NN373 09110217NN379 09420216NN373 09520217NN379
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
  • 제품 설명
    TMJ Components: || Right Ramus Component - DelCristo Catalog: 09-11-0215, || TMJ - Shah Catalog: 09-42-0217, 09-11-0217. || Left Fossa Component - DelCristo Catalog 09-42-0216, || Left Ramus Component - DelCristo Catalog: 09-11-0216.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
  • 제조사 모회사 (2017)
  • Source
    USFDA