Device Recall R3 Forte Ceramic Liners

  • Model / Serial
    09JT35383
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    09ET31294, 09FT32646M 09FT32802, 09FT32803, and 09FT33252
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 || Usage: Primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis or traumatic arthritis
  • Manufacturer
  • Model / Serial
    09FT32385, 09FT32566, 09GT34366, 09GT34367, and 09HT34777
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
  • Manufacturer
  • Model / Serial
    09FT32383, 09FT32504, 09GT33518, 09GT33519, 09GT33918, 09GT33919, 09GT34111, 09GT34112, 09KT36378, and 09MT38082
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
  • Manufacturer
  • Model / Serial
    09BT29050, 09BT29051, 09BT29052, 09BT29053, 09CT29212, 09CT29213, 09DT30919, 09DT303920, 09DT31160, 09DT31161, 09DT31162, 09FT32751, 09GT33613, 09GT34388, 09KT36368, and 09KT36369
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
  • Manufacturer
  • Model / Serial
    09DT30917, 09ET31916, 09ET31977, 09FT32386, 09FT32854, 09GT33389, 09GT33893, 09GT33894, 09HT34767, 09HT34768, 09HT34769, and 09JT35381
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, WA, and WI
  • Product Description
    R3 TM CERAMIC ACETABULAR LINER, BIOLOX¿ FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
  • Manufacturer