Device Recall Guided Handle Kit

  • Model / Serial
    Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.
  • Product Description
    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. || The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Implant Direct Sybron Manufacturing, LLC, 3050 E Hillcrest Dr, Westlake Village CA 91362-3171
  • Manufacturer Parent Company (2017)
  • Source
    USFDA