Device Recall Extremity Medical Disposable Instrument 1.6 mm Guidewire

  • Model / Serial
    Catalog Number 101-00006; Lot Number 00921538.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
  • Product Description
    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Extremity Medical LLC, 300 Interpace Pkwy Ste 410A, Parsippany NJ 07054-1148
  • Manufacturer Parent Company (2017)
  • Source
    USFDA