Device Recall Enduramesh Corpectomy Spacer System

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Lucero Medical LLC, 6100 Oak Tree Blvd Ste 200, Independence OH 44131-6914
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA Nationwide Distribution - in the state of OH.
  • Description du dispositif
    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