Device Recall DePuy Custom Implant Devices

  • Model / Serial
  • Distribution
    US Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, HI, IA, ID, IL, IN, KS, KY, LA, MA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Product Description
    DePuy Custom Implant Devices || Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product || Product Usage: || Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976. Intended Use: See information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source
    USFDA