Device Recall ENDURAMESH CORPECTOMY SPACER SYSTEM

  • 모델명 / 제조번호(시리얼번호)
    Part # 762.010, Lot # 110738; Part # 762.019, Lot # 90611, Lot #, 100308; Part # 762.021, Lot # 100308, Lot #, 110106; Part # 762.023, Lot # 90611, Lot # 100218, Lot # 100706, Lot # 110709; Part # 762.025, Lot # 90611, Lot # 100218, Lot #, 110106; Part # 762.027, Lot # 100706; Part # 762.029, Lot # 90611; Part # 762.033, Lot # 90611, Lot # 91002; Part # 762.041, Lot # 90611; Part # 762.043, Lot # 90611; Part # 762.045, Lot # 90611; Part # 762.047, Lot # 90611; Part # 762.049, Lot # 90611; Part # 762.051, Lot # 90611; Part # 762.053, Lot # 90611; Part # 762.090-2.0, Lot # 100206; Part # 762.090-2.5, Lot # 100206; Part # 762.237, Lot # 91002; Part # 762.243, Lot # 91018; Part # 762.270, Lot # 91018; Part # 762.290, Lot # 91018; Part # 762.731, Lot # 91018; Part # 762.735, Lot # 91002; Part # 762.767, Lot # 91018 & Part # 762.790, Lot # 91018.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Nationwide Distribution - in the state of OH.
  • 제품 설명
    ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 || Product Usage: || Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. The Enduramesh vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients. Indications for Use: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autoograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Lucero Medical LLC, 400 Wakefield Run Blvd, Hinckley OH 44233-9251
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Part #-Lot # (s): 762.010L-110738; 762.013L-110738; 762.017L-60611, 90611, and 512171; 762.019L-60611, 90611, 100308, 1261901, and 20121901; 762.021L-60611, 90611, 100308, 110106, 20122101, and 20122102; 762.023L- 90611, 100209, 100218, 00706, 10709, 20122301, and 20122302; 762.025L-90611, 100218, 110106, 20122501, and 20122502; 762.027L-60611, 90611, 100706, and 20122071; 762.029L-90611, 1262901, and 90611; 762.031L-1263101; 762.033L-90611, 91002, and 1263301; 762.041L-90611 and 1264101; 762.043L-90611 and 1264301; 762.045L-90611; 762.047L-90611; 762.049L-90611; 762.051L-90611 and 512511; 762.053L-90611; 762.090L-90611; 762.090L-2.0-100206 and 100342; 762.090L-2.5-100206; 762.159L-110505; 762.237L-91002; 762.243L-91018; 762.270L-91018; 762.290L-91018; 762.731L-91018; 762.735L-91002; 762.767L-91018; and 762.790L-91018.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Enduramesh Corpectomy Spacer System || Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
  • Manufacturer