Device Recall Wilson Penile Implantation System Retractor Frame,

  • Model / Serial
    Part #: TLC5042 & TLC5042-I
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
  • Product Description
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize || Product Usage: || Indicated to aid in tissue retraction during a surgical procedure.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Applied Medical Technology Inc, 8000 Katherine Blvd, Brecksville OH 44141-4202
  • Manufacturer Parent Company (2017)
  • Source
    USFDA