Device Recall EXp Tibial Insert

  • Model / Serial
    part numbers SC3425 and SC3453, with lot numbers:28592-103112 28593-102412 28602-110112 28603-110112 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31031-121013 31033-121013 31040-121013 31249-022514 31261-020414 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31040-121013 31043-120913 31243-022414 31244-022414 31249-022514 31252-021314 31255-020414 31261-020414 32083-080714 31028-120913 31031-121013 31032-121013 31033-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31029-120913 31034-120913 31040-121013 31043-120913 31044-120913 31249-022514 31255-020414 32083-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812 28624-112812 31028-120913 31029-120913 31031-121013 31032-121013 31033-121013 31034-120913 31037-121013 31040-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31252-021314 31255-020414 31261-020414 31263-021314 31265-031114 32081-080714 28592-103112 28593-102412 28598-111412 28599-111412 28602-110112 28603-110112 28613-110112 28622-112812 28623-112812 28624-112812 31034-120913 28599-111412 28617-110112 31028-120913 31032-121013 31042-121013 31044-120913 31243-022414 31244-022414 31245-022414 31249-022514 31251-022514 31252-021314 31255-020414 31261-020414 31263-021314 31264-031114 31265-031114 31266-031114 28618-110112 28592-103112 28598-103112 28599-111412 28602-110112 28603-110112 28607-111912 28613-110112 28617-110112 28618-110112 28622-112812 28623-112812
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
  • Product Description
    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
  • Manufacturer Parent Company (2017)
  • Source
    USFDA