Devices

Torque Limiting Handle

  • Model / Serial
    The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
  • Product Description
    Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
  • Manufacturer
    Theken Spine LLC
  • 1 Event

Manufacturer

Theken Spine LLC
  • Manufacturer Address
    Theken Spine LLC, 283 E Waterloo Rd, Akron OH 44319-1238
  • Source
    USFDA

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  • Product Description
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  • Manufacturer
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vitality t27 final screwdriver and vitality torque limiter (torque limiting handle) 90 in-lbs
Device Recall Torque Limiting Handle (Aspen/ Alpine)
  • Model / Serial
    538133,538134,548080,550475,552169,553131,553710,558873,567568,569141  Part Number: 6200-1109 2009300344 to 2009300543  2009300544 to 2009300643  2009300644 to 2009300743  2009300744 to 2009300843  2009300844 to 2009300993  2009411328 to 2009411377  2010082160 to 2010082257  2010152507 to 2010152571  2010373025 to 2010373174
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 || Product Usage: || Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
  • Manufacturer
    Biomet Spine, LLC
Device Recall Atlas Spine Torque Limiting Handle
  • Model / Serial
    Lots #: 8887, 000073, 000135, 00434, and 02518.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution to FL, MO, and WV.
  • Product Description
    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 || Used to rotate implant into position
  • Manufacturer
    Atlas Spine, Inc.
Device Recall Synthes Torque Limiting Handle
  • Model / Serial
    H344006-02,  H344006-03,  H344006-04,  H344006-05,  H344006-06,  H344006-07,  H344006-08,  H344006-09,  H344006-10,  H344006-11,  H344006-12,  H344006-13,  H344006-14,  H344006-15,  H344006-16,  H344006-17,  H344006-18,  H344006-19,  H344006-20,  H344006-21,  H344006-22,  H344006-23,  H344006-24,  H344006-25,  H344006-26,  H344006-27,  H344006-28,  H344006-29,  H344006-30,  H344006-31,  H344006-32,  H344006-33,  H344006-34,  H344006-35,  H344006-36,  H344006-37,  H344006-38,  H344006-39,  H344006-40,  H344006-41,  H344006-43,  H344006-45,  H344006-46,  H344006-47,  H344006-48,  H344006-49,  H369323-03,  H369323-04
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.
  • Product Description
    Synthes Torque Limiting Handle, Part Number 03.231.013 || This device is used in systems indicated for fracture fixation.
  • Manufacturer
    Synthes (USA) Products LLC
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