Devices

Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • 제품 설명
    Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
  • Manufacturer
    Blackstone Medical, Inc.
  • 1 Event

제조사

Blackstone Medical, Inc.
  • 제조사 주소
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • 제조사 모회사 (2017)
    Orthofix Medical, Inc.
  • Source
    USFDA