Manufacturers

Spinal Solutions, LLC

11 devices in the database

Device Recall APLIF Implants and Instruments
  • Model / Serial
    All lots are subject to this recall.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NV, WI, MD,and CA.
  • Product Description
    APLIF Implants and Instruments, || Part Numbers: || 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree || 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree || 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree || 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree || 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree || 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree || 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree || 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree || 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree || 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree || 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree || 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree || 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree || 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree || 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree || 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree || 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree || 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree || 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree || 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree || 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree || 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree || 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree || 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree || 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree || 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree || 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree || 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree || 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree || 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree || 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree || 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree || 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree || 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm - 10degree || 185508-00 Anterior Psoas Lumbar 18 x 55 x 08mm - 00degree || 185510-00 Anterior Psoas Lumbar 18 x 55 x 10mm - 00degree || 185512-00 Anterior Psoas Lumbar 18 x 55 x 12mm - 00degree || 185514-00 Anterior Psoas Lumbar 18 x 55 x 14mm - 00degree || 185516-00 Anterior Psoas Lumbar 18 x 55 x 16mm - 00degree || The Eminent Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment.
Device Recall PEDICLE SCREW SYSTEM
  • Model / Serial
    Item #BG7045
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Product Description
    45 mm Screw, Item #BG7045 || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Device Recall SPINE INTERBODY FUSION SYSTEM
  • Model / Serial
    Item # C5006 C5007 C5008 C5009 C5010 C5011
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Product Description
    Copperhead IBFD, Large Neutral, 6mm || Copperhead IBFD, Large Neutral, 7mm || Copperhead IBFD, Large Neutral, 8mm || Copperhead IBFD, Large Neutral, 9mm || Copperhead IBFD, Large Neutral, 10mm || Copperhead IBFD, Large Neutral, 11mm || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Device Recall PEDICLE SCREW SYSTEM
  • Model / Serial
    Item #BG7050
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Product Description
    50 mm Screw, Item #BG7050 || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Device Recall PEDICLE SCREW SYSTEM
  • Model / Serial
    Item #BG3010
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Product Description
    Set Screw, Item #BG3010 || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
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