Devices

Device Recall THandle

  • Model / Serial
    Lot Numbers: 1335201A, 1446101A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of MA, NV and TX.
  • Product Description
    T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A || T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
  • Manufacturer
    SpineFrontier, Inc.
  • 1 Event

Manufacturer

SpineFrontier, Inc.
  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
    SpineFrontier, Inc.
  • Source
    USFDA

One device with a similar name

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Device Recall THandle Driver
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AR, AZ, CA, CT, CO, FL, IL, LA, MD, MI, MO, MN, MT, NC, NM, NJ, NY, OH, OK, OR, PA, SD, TX, VA and WI.
  • Product Description
    PathFinder¿ Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727.
  • Manufacturer
    Abbott Spine