Device Recall Synthes drill bit for 5.0mm Recon Screws/Large QC

  • Model / Serial
    Drill Bit for 5.0mm Recon Screws/Large QC, model number 03.010.228, all lot numbers.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MI, MN, MT, LA, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TX, UT, VA, WA, WV, WI, and WY. GOVERNMENT account is Audie Murphy VA Hospital, Chief Supply Svc Whse #1, 7400 Merton Minter Blvd, San Antonio, TX 78229.
  • Product Description
    Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source
    USFDA